Q2 2026 Guardant Health Inc Earnings Call

Speaker #1: Hello everyone, thank you for joining us, and welcome to the Gardened Health Q2 2026 earnings call. After today's prepared remarks, we will host a Q&A session.

Speaker #1: If you would like to ask a question, please press *1 to raise your hand. To withdraw your question, please press *1 again. I will now hand the conference over to Zarek Khurshid, VP of Investor Relations.

Speaker #1: Zarek, please go ahead.

Speaker #1: Hello everyone. Thank you for joining us, and welcome to the Guardant Health second quarter 2026 earnings call. After today's prepared remarks, we will host a Q&A session.

Speaker #2: Thank you. Earlier today, Garden Health released financial results for the quarter ended June 30, 2026. Joining me today from Gardened are co-CEOs Helmi Otuqi and Emirali Talasaz, the Chief Financial Officer Mike Bell.

Speaker #1: If you would like to ask a question, please press *1 to raise your hand. To withdraw your question, please press *1 again. I will now hand the conference over to Zarak Khurshid, VP of Investor Relations.

Speaker #2: Before we begin, I'd like to remind you that during this call we will be making forward-looking statements within the meaning of federal securities laws.

Speaker #2: These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items.

Speaker #1: Zarak, please go ahead.

Speaker #2: Thank you. Earlier today, Guardant Health released financial results for the quarter ended June 30, 2026. Joining me today from Guardant are co-CEOs Helmy Eltoukhy and AmirAli Talasaz, and Chief Financial Officer Michael Bell.

Speaker #2: Additional information regarding material risks and uncertainties as well as the non-GAAP financial reconciliation to most directly comparable GAAP financial measures are available in the press release Gardened issued today, as well as in our 10Q and other filings with the SEC.

Speaker #2: Before we begin, I'd like to remind you that during this call we will be making forward-looking statements within the meaning of federal securities laws.

Speaker #2: These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items.

Speaker #2: Gardened disclaims any intention or obligation to update or revise financial projections and forward-looking statements whether because of new information, future events, or otherwise, except as required by law.

Speaker #2: Additional information regarding material risks and uncertainties, as well as the non-GAAP financial reconciliation to the most directly comparable GAAP financial measures, are available in the press release Guardant issued today, as well as in our 10-Q and other filings with the SEC.

Speaker #2: The information in this conference call is accurate only as of the live broadcast, with that I would like to turn the call over to Helmi.

Speaker #3: Thanks, Zarek. Good afternoon, and thank you for joining our Q2 2026 earnings call. Starting on slide 3, the platform we have built at Gardened is enabling 4 of the largest opportunities in precision medicine.

Speaker #2: Guardant disclaims any intention or obligation to update or revise financial projections and forward-looking statements whether because of new information, future events, or otherwise, except as required by law.

Speaker #3: Therapy selection, recurrence monitoring, cancer screening, and ultimately multi-disease screening. Together, these represent nearly 400 billion dollars in potential markets, all powered by the same smart platform and the compounding technology data and clinical insights it generates across the disease continuum.

Speaker #2: The information in this conference call is accurate only as of the live broadcast. With that, I would like to turn the call over to Helmy.

Speaker #3: Thanks, Zarak. Good afternoon, and thank you for joining our second quarter 2026 earnings call. Starting on slide 3, the platform we have built at Guardant is enabling four of the largest opportunities in precision medicine.

Speaker #3: Q2 was a landmark quarter in advancing that vision. During the quarter, we received FDA approval for Gardened 360 liquid CDX, as well as approval for a higher throughput, lower COGS, shield workflow.

Speaker #3: Therapy selection, recurrence monitoring, cancer screening, and ultimately multi-disease screening—together, these represent nearly $400 billion in potential markets, all powered by the same smart platform and the compounding technology, data, and clinical insights it generates across the disease continuum.

Speaker #3: In addition, we achieved 2 significant shield milestones: inclusion in the American Cancer Society's colorectal cancer screening guidelines, and just this month, a major coverage decision from the UnitedHealth Group.

Speaker #3: Together with continued broad-based growth across the business, these results demonstrate that we are steadily turning our smart platform vision into clinical impact and durable growth.

Speaker #3: Q2 was a landmark quarter in advancing that vision. During the quarter, we received FDA approval for Guardant360 Liquid CDx, as well as approval for a higher-throughput, lower-COGS Shield workflow.

Speaker #3: Before I share our results in more detail, I'd like to share a story that illustrates the real-world impact of our tests. Maria was a 46-year-old mother of 2 living with metastatic breast cancer.

Speaker #3: In addition, we achieved two significant Shield milestones: inclusion in the American Cancer Society's Colorectal Cancer Screening Guidelines, and, just this month, a major coverage decision from UnitedHealth Group.

Speaker #3: After surgery, chemotherapy, endocrine therapy, and later progression on multiple lines of treatment, her care team faced a familiar but frustrating question: what next? Her disease had become harder to control.

Speaker #3: Together with continued broad-based growth across the business, these results demonstrate that we are steadily turning our smart platform vision into clinical impact and durable growth.

Speaker #3: Before I share our results in more detail, I'd like to share a story that illustrates the real-world impact of our tests. Maria was a 46-year-old mother of two living with metastatic breast cancer.

Speaker #3: If she was limited from prior biopsies, it may not be representative of her current disease, and another invasive procedure would have delayed treatment decisions.

Speaker #3: Her oncologist ordered a Gardened 360 liquid test to provide a comprehensive real-time view of her cancer, through a blood draw. The results changed the conversation.

Speaker #3: After surgery, chemotherapy, endocrine therapy, and later progression on multiple lines of treatment, her care team faced a familiar but frustrating question: what next? Her disease had become harder to control.

Speaker #3: Gardened 360 liquid identified homologous recombination deficiency, or HRD, which occurs when cells lose their ability to accurately repair double-stranded DNA breaks. Armed with this new biological insight, Maria's care team had greater confidence that her cancer may be more responsive to a DNA damage response strategy as opposed to another empiric chemotherapy.

Speaker #3: Tissue was limited from prior biopsies and may not be representative of her current disease, and another invasive procedure would have delayed treatment decisions. Her oncologist ordered a Guardant360 liquid test to provide a comprehensive, real-time view of her cancer through a blood draw.

Speaker #3: Maria's oncologist shifted her treatment plan to a biomarker-informed approach that included platinum-based therapy, which responded well to, with manageable side effects. Turning to our revenue performance in slide 4, we delivered 335 million dollars of revenue in the Q2, representing 44% year-over-year growth.

Speaker #3: The results changed the conversation. Guardant360 liquid identified homologous recombination deficiency, or HRD, which occurs when cells lose their ability to accurately repair double-stranded DNA breaks.

Speaker #3: Armed with this new biological insight, Maria's care team had greater confidence that her cancer may be more responsive to a DNA damage response strategy, as opposed to another empiric chemotherapy.

Speaker #3: The growth is strong in broad base across our oncology, biopharma, and data, and screening business lines. Taking a closer look at our oncology business in slide 5, oncology revenue grew 38% year-over-year, driving Q2 revenue of 219 million dollars.

Speaker #3: Maria's oncologist shifted her treatment plan to a biomarker-informed approach that included platinum-based therapy, which she responded well to, with manageable side effects. Turning to our revenue performance in slide 4, we delivered $335 million of revenue in the second quarter, representing 44% year-over-year growth.

Speaker #3: Oncology test volumes rose 63% to approximately 104,000 tests up from 64,000 in the prior year period, with strength across all products. Turning to slide 6, the tremendous 63% growth in oncology volume represented another quarter of acceleration, reflecting the increasing strength of our portfolio across both therapy selection and MRD.

Speaker #3: The growth was strong and broad-based across our oncology, biopharma, and data, and screening business lines. Taking a closer look at our oncology business in slide 5, oncology revenue grew 38% year-over-year, driving Q2 revenue of 219 million dollars.

Speaker #3: Gardened 360 liquid year-over-year volume growth accelerated from the first quarter delivering greater than 30% growth, benefiting from continued smart platform adoption. Gardened 360 tissue volume growth also accelerated in the quarter, and remains our second fastest growing product.

Speaker #3: Oncology test volumes rose 63% to approximately 104,000 tests, up from 64,000 in the prior year period, with strength across all products. Turning to slide 6, the tremendous 63% growth in oncology volume represented another quarter of acceleration, reflecting the increasing strength of our portfolio across both therapy selection and MRD.

Speaker #3: Reveal continues to be our fastest growing product, with volume growth accelerating again to more than 100% year-over-year, reflecting continued strength in MRD and growing adoption of the therapy monitoring use case.

Speaker #3: Guardant360 liquid year-over-year volume growth accelerated from the first quarter, delivering greater than 30% growth, benefiting from continued Smart Platform adoption. Guardant360 tissue volume growth also accelerated in the quarter and remains our second-fastest growing product.

Speaker #3: Moving to slide 7, I wanted to spend a moment on what we believe is one of our most underappreciated assets: our data. Every patient we test deepens a proprietary data asset that is difficult, if not impossible, for others to replicate.

Speaker #3: Reveal continues to be our fastest-growing product, with volume growth accelerating again to more than 100% year-over-year, reflecting continued strength in MRD and growing adoption of the therapy monitoring use case.

Speaker #3: Today, that repository spans more than 1.3 million patient tests and over 700,000 epigenetic profiles, across more than 100 tumor types. This is the raw fuel that powers Infinity AI, enabling the discovery of novel biological signatures.

Speaker #3: Moving to slide 7, I want to spend a moment on what we believe is one of our most underappreciated assets: our data. Every patient we test deepens a proprietary data asset that is difficult, if not impossible, for others to replicate.

Speaker #3: The development of new clinically actionable smart apps, and the acceleration of drug discovery for our biopharma partners. At ASCO in June, we showcased several innovative new tools built on our Infinity AI platform, and we are seeing a very strong positive response.

Speaker #3: Today, that repository spans more than 1.3 million patient tests and over 700,000 epigenetic profiles, across more than 100 tumor types. This is the raw fuel that powers Infinity AI, enabling the discovery of novel biological signatures.

Speaker #3: Turning to slide 8, in May we received FDA approval for Gardened 360 liquid CDX, the most advanced FDA-approved liquid biopsy panel, with 100 times more content versus our legacy FDA-approved CDX product.

Speaker #3: The development of new, clinically actionable smart apps, and the acceleration of drug discovery for our biopharma partners. At ASCO in June, we showcased several innovative new tools built on our Infinity AI platform, and we are seeing a very strong, positive response.

Speaker #3: Gardened 360 liquid CDX is significant for several reasons. Most notably, it reinforces Gardened's leadership in the field of liquid CGP testing, with Gardened 360 liquid CDX representing the only FDA-approved liquid biopsy test integrating both genomic and epigenomic content.

Speaker #3: Turning to slide 8, in May we received FDA approval for Guardant360 Liquid CDx, the most advanced FDA-approved liquid biopsy panel, with 100 times more content versus our legacy FDA-approved CDx product.

Speaker #3: Over time, Gardened 360 liquid CDX will help to simplify our therapy selection portfolio by consolidating multiple offerings into a single product. It also excited by the potential for Gardened 360 liquid CDX to complement Gardened 360 tissue to drive greater adoption.

Speaker #3: Guardant360 Liquid CDx is significant for several reasons. Most notably, it reinforces Guardant's leadership in the field of liquid CGP testing, with Guardant360 Liquid CDx representing the only FDA-approved liquid biopsy test integrating both genomic and epigenomic content.

Speaker #3: We remain on track to obtain ADLT designation for Gardened 360 liquid CDX in the first half of 2027. In June, we began a phased rollout of Gardened 360 liquid CDX to our U.S.

Speaker #3: Over time, Guardant360 Liquid CDx will help to simplify our therapy selection portfolio by consolidating multiple offerings into a single product. We are also excited by the potential for Guardant360 Liquid CDx to complement Guardant360 Tissue to drive greater adoption.

Speaker #3: customers, and we plan to offer widespread availability of the test following ADLT designation. This approach is intended to ensure a smooth reimbursement transition to the new test.

Speaker #3: The FDA approval in the Q2 represents one of the most significant regulatory milestones in our company's history, and the feedback from customers thus far has been incredibly strong.

Speaker #3: We remain on track to obtain ADLT designation for Guardant360 Liquid CDx in the first half of 2027. In June, we began a phased rollout of Guardant360 Liquid CDx to our U.S.

Speaker #3: Turning to slide 9, Reveal continues to perform at an extremely high level, with volume growth accelerating for the Q3 in a row to well above 100% year-over-year.

Speaker #3: customers, and we plan to offer widespread availability of the test following ADLT designation. This approach is intended to ensure a smooth reimbursement transition to the new test.

Speaker #3: We believe Reveal remains the most validated and highest-performing tissue-free MRD solution, with a 5-day turnaround time. Once again, we experienced strong MRD uptake in the Q2 across major indications, and Reveal Therapy Monitoring continues to stand out as a major volume growth driver in its second full quarter after launch.

Speaker #3: The FDA approval in the second quarter represents one of the most significant regulatory milestones in our company's history, and the feedback from customers thus far has been incredibly strong.

Speaker #3: Turning to slide 9, Reveal continues to perform at an extremely high level, with volume growth accelerating for the third quarter in a row to well above 100% year-over-year.

Speaker #3: Reveal is uniquely suited for therapy monitoring in late-stage cancer, helping predict therapy response months before imaging, and with seamless connectivity to Gardened 360 liquid, it can help physicians to act sooner and with more precision.

Speaker #3: We believe Reveal remains the most validated and highest-performing tissue-free MRD solution, with a five-day turnaround time. Once again, we experienced strong MRD uptake in the second quarter across major indications, and Reveal therapy monitoring continues to stand out as a major volume growth driver in its second full quarter after launch.

Speaker #3: Late-stage cancer therapy monitoring alone is a multi-million test annual opportunity that remains largely untapped. We continue to be excited about the commercial momentum behind Reveal, and we remain on track to launch Reveal Ultra later this year, which we believe will be the most sensitive tumor-informed MRD test.

Speaker #3: Reveal is uniquely suited for therapy monitoring in late-stage cancer, helping predict therapy response months before imaging. With seamless connectivity to Guardant360 liquid, it can help physicians act sooner and with more precision.

Speaker #3: Turning to slide 10, we continue to make progress advancing our Reveal data and publication pipeline. As a reminder, we have submitted data to Moldex for coverage for breast cancer surveillance, immuno-oncology monitoring, and chemotherapy monitoring, and those initiatives continue to progress.

Speaker #3: Late-stage cancer therapy monitoring alone is a multimillion-test annual opportunity that remains largely untapped. We continue to be excited about the commercial momentum behind Reveal, and we remain on track to launch Reveal Ultra later this year, which we believe will be the most sensitive tumor-informed MRD test.

Speaker #3: Shifting to our biopharma and data business in slide 11, revenue grew 9% year-over-year to 61 million dollars, which marks a record quarter. Our companion diagnostic franchise continues to build momentum.

Speaker #3: Turning to slide 10, we continue to make progress advancing our Reveal data and publication pipeline. As a reminder, we have submitted data to MolDx for coverage for breast cancer surveillance, immuno-oncology monitoring, and chemotherapy monitoring, and those initiatives continue to progress.

Speaker #3: We now have 28 CDX approvals, with 4 added in the first half of this year alone. This reflects a strategic value for smart platform to leading biopharma companies.

Speaker #3: During the quarter, we received FDA approval for Gardened 360 CDX as a companion diagnostic for Boehringer Ingelheim's for Nexios, the first targeted therapy approved for adults with HER2 or ERBB2 mutant advanced non-small cell lung cancer as an initial treatment option.

Speaker #3: Shifting to our biopharma and data business on slide 11, revenue grew 9% year-over-year to $61 million, which marks a record quarter. Our companion diagnostic franchise continues to build momentum — we now have 28 CDx approvals, with 4 added in the first half of this year alone.

Speaker #3: We also received FDA approval for Gardened 360 CDX as a companion diagnostic for our venous and Pfizer's Papano for ER-positive HER2-negative ESO1 mutated advanced breast cancer.

Speaker #3: This reflects a strategic value for smart platform to leading biopharma companies. During the quarter, we received FDA approval for Guardant 360 CDX as a companion diagnostic for Boehringer Ingelheim's for Nexios, the first target therapy approved for adults with HER2 or ERBB2 mutant advanced non-small cell lung cancer, as an initial treatment option.

Speaker #3: We also announced a collaboration with NewValent to develop companion diagnostics with an initial focus on Gardened 360 tissue. With that, I'll now turn the call over to Amir Ali for an update on screening.

Speaker #1: Thank you, Helmi. Moving on to slide 12, we developed Shield from the ground up as a multi-cancer detection platform. Shield is clinically validated for detection of 10 different cancer types and is approved by the FDA for colorectal cancer screening as its first indication.

Speaker #3: We also received FDA approval for Guardant360 CDx as a companion diagnostic for our venous and Pfizer's Papanno for ER-positive, HER2-negative, ES01-mutated advanced breast cancer.

Speaker #3: We also announced a collaboration with NewValent to develop companion diagnostics, with an initial focus on Guardant360 Tissue. With that, I'll now turn the call over to AmirAli for an update on screening.

Speaker #1: When a physician orders a Shield blood test for CRC screening, they can opt in to receive multi-cancer detection results report covering 9 additional cancer types beyond CRC.

Speaker #1: Thank you, Helmy. Moving on to slide 12, we developed Shield from the ground up as a multi-cancer detection platform. Shield is clinically validated for the detection of 10 different cancer types and is approved by the FDA for colorectal cancer screening as its first indication.

Speaker #1: The release of this report is contingent on patient authorizing the release of their medical records to Gardened as part of our data collection initiative.

Speaker #1: You're very pleased with the progress in multi-cancer data collection, and are excited to see the majority of Shield ordering physicians opting in to receive MCD reports.

Speaker #1: When a physician orders a Shield blood test for CRC screening, they can opt in to receive multi-cancer detection results reports covering nine additional cancer types, beyond CRC.

Speaker #1: With colorectal cancer screening still representing such a significant unmet need, CRC remains our primary commercial focus. Now, moving on to slide 13 for an update on the screening business.

Speaker #1: The release of this report is contingent on patient authorizing the release of their medical records to Guardant as part of our data collection initiative.

Speaker #1: Q2 was another fantastic quarter for Shield. We delivered 53 million dollars of Shield testing revenue, driven by approximately 66,000 tests. Compared to 15 million dollars of revenue and approximately 16,000 tests in Q12 2025.

Speaker #1: You're very pleased with the progress in multi-cancer data collection, and are excited to see the majority of Shield ordering physicians opting in to receive MCD reports.

Speaker #1: With colorectal cancer screening still representing such a significant unmet need, CRC remains our primary commercial focus. Now, moving on to Slide 13 for an update on the screening business.

Speaker #1: Turning to slide 14, which shows the evolution of Shield sales over the last 8 quarters, overlaid with the important guidelines, commercial partnerships, and coverage wins that have been instrumental in driving recent demand and that gives us confidence in future growth.

Speaker #1: Due to another fantastic quarter for Shield, we delivered $53 million of Shield testing revenue, driven by approximately 66,000 tests. This compares to $15 million of revenue and approximately 16,000 tests in Q2 2025.

Speaker #1: I will discuss a few of these significant wins in greater detail shortly. We are now well into our second year of commercial launch, and the business continues to fire on all cylinders.

Speaker #1: Turning to slide 14, which shows the evolution of Shield sales over the last 8 quarters, overlaid with the important guidelines, ES, commercial partnerships, and coverage wins that have been instrumental in driving recent demand and that give us confidence in future growth.

Speaker #1: Moving on to slide 15 to discuss our major screening highlights. We saw exceptionally strong volume growth in the quarter, driven by commercial-scale DTC momentum and our Quaise collaboration.

Speaker #1: Shield was included in the American Cancer Society's Colorectal Cancer Screening Guidelines, making Shield the only FDA-approved blood test included in both ACS and NCCN guidelines.

Speaker #1: I will discuss a few of these significant wins in greater detail shortly. We are now well into our second year of commercial launch, and the business continues to fire on all cylinders.

Speaker #1: And UnitedHealth Health Group, the largest commercial insurer in the United States, announced it will begin covering Shield for colorectal cancer screening in adults 45 and older.

Speaker #1: Moving on to slide 15 to discuss our major screening highlights. We saw exceptionally strong volume growth in the quarter, driven by commercial-scale DTC momentum and our Quaise collaboration.

Speaker #1: Moreover, we are excited to report that last week we received FDA approval for a higher throughput lower-cog Shield workflow. Let's focus on the latest scaled Shield commercial engine on slide 16.

Speaker #1: Shield was included in the American Cancer Society's colorectal cancer screening guidelines, making Shield the only FDA-approved blood test included in both ACS and NCCN guidelines.

Speaker #1: Shield's commercial reach continues to expand rapidly on personal promotion, campaigns, health system engagements, and email connectivity. We are happy to report that our field organization now stands at over 400 professionals nationwide.

Speaker #1: And UnitedHealth Group, the largest commercial insurer in the United States, announced it will begin covering Shield for colorectal cancer screening in adults 45 and older.

Speaker #1: Moreover, we are excited to report that last week we received FDA approval for a higher throughput lower-cog Shield workflow. Let's focus on the latest scaled Shield commercial engine on slide 16.

Speaker #1: In addition to our internal sales team, the Quaise collaboration has been a success. We are encouraged with how nationwide EMR access and co-commercial activities with their team have developed in the first full quarter since the relationship went live in the field.

Speaker #1: Shield's commercial reach continues to expand rapidly, driven by personal promotion, campaigns, health system engagements, and email connectivity. We are happy to report that our field organization now stands at over 400 professionals nationwide.

Speaker #1: In addition to these initiatives, we have built and expanded our dedicated health system team to more than 30 people and have been encouraged by the engagement within large accounts.

Speaker #1: In addition to our internal sales team, the Quaise collaboration has been a success. We are encouraged with how nationwide EMR access and co-commercial activities with their team have developed in the first full quarter since the relationship went live in the field.

Speaker #1: Turning to slide 17, patient access to Shield blood test continues to expand at a rapid rate. Shield was added to the NCCN guidelines in June 2025 and to the American Cancer Society guidelines in May 2026.

Speaker #1: ACS guideline inclusion is particularly important because it triggers state-level coverage mandates in roughly a dozen states for commercial payers. An exciting result of these guidelines wins has been positive momentum in our payer discussions, and the sooner than expected UnitedHealth Health coverage policy update that I mentioned earlier.

Speaker #1: In addition to these initiatives, we have built and expanded our dedicated health system team to more than 30 people and have been encouraged by the engagement within large accounts.

Speaker #1: Turning to slide 17, patient access to Shield blood tests continues to expand at a rapid rate. Shield was added to the NCCN guidelines in June 2025 and to the American Cancer Society guidelines in May 2026.

Speaker #1: This coverage will be effective starting on August 1, which includes Shield as a covered primary colorectal cancer screening option for average risk adults age 45 and older.

Speaker #1: ACS guideline inclusion is particularly important because it triggers state-level coverage mandates in roughly a dozen states for commercial payers. An exciting result of these guideline wins has been positive momentum in our payer discussions, and the sooner-than-expected UnitedHealth coverage policy update that I mentioned earlier.

Speaker #1: UnitedHealth Health is the largest commercial insurer in the US, and the first major insurer to cover Shield. Turning to slide 18, to put these commercial coverage wins into context.

Speaker #1: There are approximately 120 million average risk individuals in US eligible for colorectal cancer screening, representing a 50 billion dollar US addressable screening market. As a result of ACS guideline inclusion and the UnitedHealth Health coverage policy, we believe that approximately 70 million lives, or roughly 60% of the market, is now covered for Shield blood test.

Speaker #1: This coverage will be effective starting on August 1, which includes Shield as a covered primary colorectal cancer screening option for average-risk adults age 45 and older.

Speaker #1: UnitedHealth Health is the largest commercial insurer in the US, and the first major insurer to cover Shield. Turning to slide 18, to put these commercial coverage wins into context.

Speaker #1: Turning to slide 19, last week we received FDA approval for a higher throughput lower-cog Shield workflow. And that workflow will be live in production in August for all new incoming samples.

Speaker #1: There are approximately 120 million average-risk individuals in the U.S. eligible for colorectal cancer screening, representing a $50 billion U.S. addressable screening market. As a result of ACS guideline inclusion and the UnitedHealth coverage policy, we believe that approximately 70 million lives, or roughly 60% of the market, are now covered for Shield blood tests.

Speaker #1: This workflow improvement will increase efficiency in running the test and will reduce the cost per test. Furthermore, it will improve the scalability of our existing lab operations.

Speaker #1: As a result of this development, the much stronger than expected demand and UnitedHealth Health coverage news, we are accelerating investments to continue to build our lab capacity ahead of rapidly increasing volume.

Speaker #1: Turning to slide 19, last week we received FDA approval for a higher-throughput, lower-COGS Shield workflow. And that workflow will be live in production in August for all new incoming samples.

Speaker #1: We are excited about all the progress across multiple fronts at Gardened Health. On behalf of Helmi and myself, I want to express our deepest gratitude to our leaders and the whole Gardened team watching this team's focus integrity and sheer dedication to our mission continues to inspire us both every single day.

Speaker #1: This workflow improvement will increase efficiency in running the tests and will reduce the cost per test. Furthermore, it will improve the scalability of our existing lab operations.

Speaker #1: As a result of this development, the much stronger-than-expected demand, and UnitedHealth coverage news, we are accelerating investments to continue to build our lab capacity ahead of rapidly increasing volume.

Speaker #1: With that, I now turn the call over to Mike for more detail on our financials.

Speaker #2: Thanks, Amir Ali. Turning to slide 20, our work through our second quarter results, unless otherwise noted, growth rates are year over year. Second quarter revenue reached 335 million dollars, up 44%.

Speaker #1: We are excited about all the progress across multiple fronts at Guardant Health. On behalf of Helmy and myself, I want to express our deepest gratitude to our leaders and the whole Guardant team. Watching this team's focus, integrity, and sheer dedication to our mission continues to inspire us both every single day.

Speaker #2: Growth was broad-based, with strong contributions from oncology, biopharma and data, and screening. Oncology revenue was 219 million dollars, an increase of 38%. Oncology test volume grew 63% to approximately 104,000 tests, reflecting strength across the portfolio.

Speaker #1: With that, I'll now turn the call over to my four more detail on our financials.

Speaker #2: Thanks, AmirAli. Turning to slide 20, I'll walk through our second quarter results, and unless otherwise noted, growth rates are year over year. Second quarter revenue reached $335 million, up 44%.

Speaker #2: Within the portfolio, Gardened 360 liquid volume increased more than 30%, driven by continued adoption of our smart apps. Gardened 360 tissue accelerated from first quarter levels and remained our second fastest growing oncology product, reflecting the product enhancements introduced over the past few quarters.

Speaker #2: Growth was broad-based, with strong contributions from oncology, biopharma and data, and screening. Oncology revenue was 219 million dollars, an increase of 38%. Oncology test volume grew 63% to approximately 104,000 tests, reflecting strength across the portfolio.

Speaker #2: Reveal again led the portfolio in growth, with volume more than doubling year over year, as MRD adoption expanded and therapy response monitoring contributed meaningfully.

Speaker #2: Within the portfolio, Guardant 360 liquid volume increased more than 30%, driven by continued adoption of our smart apps. Guardant 360 tissue accelerated from first quarter levels and remained our second fastest growing oncology product, reflecting the product enhancements introduced over the past few quarters.

Speaker #2: Oncology ASPs were broadly stable sequentially and our submissions to MOLDEX for Medicare reimbursement covering breast MRD and immunotherapy and chemotherapy response monitoring continue to progress.

Speaker #2: Our biopharma and data business delivered record quarterly revenue of 61 million dollars, up 9%, reflecting the increasing strategic value of our smart platform and Infinity AI offerings to biopharma partners.

Speaker #2: Reveal again led the portfolio in growth, with volume more than doubling year over year, as MRD adoption expanded and therapy response monitoring contributed meaningfully.

Speaker #2: Oncology ASPs were broadly stable sequentially, and our submissions to Multi-X for Medicare reimbursement covering breast MRD and immunotherapy and chemotherapy response monitoring continued to progress.

Speaker #2: Screening revenue was 53 million dollars, compared to 15 million a year ago. Shield volume increased to approximately 66,000 tests from 16,000 a year ago.

Speaker #2: Our biopharma and data business delivered record quarterly revenue of $61 million, up 9%, reflecting the increasing strategic value of our Smart Platform and Infinity AI offerings to biopharma partners.

Speaker #2: ASP was approximately 800 dollars per test, with reimbursement remaining strong across Medicare fee-for-service and Medicare Advantage. As expected, the mix of commercially insured patients under age 65 increased in the quarter ahead of broader reimbursement coverage.

Speaker #2: Screening revenue was 53 million dollars, compared to 15 million a year ago. Shield volume increased to approximately 66,000 tests from 16,000 a year ago.

Speaker #2: With Shield now included in ACS guidelines and UnitedHealth Healthcare coverage beginning in August, we expect the commercial mix to continue to increase in the second half of the year.

Speaker #2: ASP was approximately $800 per test, with reimbursement remaining strong across Medicare fee-for-service and Medicare Advantage. As expected, the mix of commercially insured patients under age 65 increased in the quarter ahead of broader reimbursement coverage.

Speaker #2: Turning to slide 21, Zamir Ali noted that the FDA recently approved a higher throughput lower-cog Shield workflow. in our efforts to reduce Shield cost per test.

Speaker #2: When fully implemented in our lab operations, the new workflow will produce a step-down in Shield cost per test, combined with additional efficiencies from increasing scale, we expect that by the end of 2026, Shield cost per test will reduce by roughly 15% from the current level of approximately 410 dollars.

Speaker #2: With Shield now included in ACS guidelines and UnitedHealth Healthcare coverage beginning in August, we expect the commercial mix to continue to increase in the second half of the year.

Speaker #2: Turning to slide 21, ZamirAli noted, "The FDA recently approved a higher throughput lower-cog Shield workflow." This marks a significant step forward in our efforts to reduce Shield cost per test.

Speaker #2: Beyond 2026, further scale benefits and major automation initiatives are expected to drive the next wave of reductions and support our 200 dollar cost per test target in 2028.

Speaker #2: When fully implemented in our lab operations, the new workflow will produce a step-down in Shield cost per test. Combined with additional efficiencies from increasing scale, we expect that by the end of 2026, Shield cost per test will reduce by roughly 15% from the current level of approximately $410.

Speaker #2: Turning to slide 22, second quarter non-gap gross margin was 67%, compared with 66% a year ago. The improvement reflects lab efficiency, disciplined execution, and tight cost control.

Speaker #2: Beyond 2026, further scale benefits and major automation initiatives are expected to drive the next wave of reductions and support our $200 cost per test target in 2028.

Speaker #2: As planned, we completed the Gardened 360 liquid transition to Novotec X in May, reducing cost per test by approximately 200 dollars. That benefit together with the planned Shield cost reductions will help support continued strong gross margins in the second half, even as our product mix continues to evolve.

Speaker #2: Turning to slide 22, second quarter non-GAAP gross margin was 67%, compared with 66% a year ago. The improvement reflects lab efficiency, disciplined execution, and tight cost control.

Speaker #2: Non-gap operating expenses were 288 million dollars, up 34%, with the increase concentrated in commercial investment. Sales and marketing expense was 172 million dollars, compared with 108 million a year ago, as we continue to expand the screening sales infrastructure advanced Shield HCP and DTC programs and supported oncology growth.

Speaker #2: As planned, we completed the Guardant 360 liquid transition to Novitec X in May, reducing the cost per test by approximately $200. That benefit, together with the planned Shield cost reductions, will help support continued strong gross margins in the second half, even as our product mix continues to evolve.

Speaker #2: Adjusted EBITDA loss was 56 million dollars, compared with a loss of 52 million dollars in the second quarter of 2025. Quarter-end cash and investments were approximately 1.2 billion dollars, and free cash flow burn in Q2 was 70 million dollars, compared with 66 million a year ago.

Speaker #2: Non-gap operating expenses were 288 million dollars of 34%, with the increase concentrated in commercial investment. Sales and marketing expense was 172 million dollars, compared with 108 million a year ago, as we continue to expand the screening sales infrastructure advanced Shield HCP and DTC programs and supported oncology growth.

Speaker #2: The year-over-year increase was due to additional capex investment in screening lab automation and broader infrastructure to support higher test volumes, greater processing efficiency, and improved turnaround times.

Speaker #2: Adjusted EBITDA loss was $56 million, compared with a loss of $52 million in the second quarter of 2025. Quarter-end cash and investments were approximately $1.2 billion, and free cash flow burn in Q2 was $70 million, compared with $66 million a year ago.

Speaker #2: Turning to slide 23, our first half results and the progress since our last call give us greater visibility into the balance of the year.

Speaker #2: We are raising full-year 2026 revenue guidance to a range of 1.34 billion to 1.36 billion dollars, representing growth of 36 to 38 percent. For oncology, we now expect revenue growth of approximately 30% and volume growth of approximately 50%.

Speaker #2: The year-over-year increase was due to additional CapEx investment in screening lab automation and broader infrastructure to support higher test volumes, greater processing efficiency, and improved turnaround times.

Speaker #2: Turning to slide 23, our first half results and the progress since our last call give us greater visibility into the balance of the year.

Speaker #2: The outlook reflects continued smart app adoption of Gardened 360 liquid, strong commercial execution, and the impact of recent product upgrades in Gardened 360 tissue, as well as continued growth in Reveal across MRD and therapy monitoring.

Speaker #2: We are raising full-year 2026 revenue guidance to a range of 1.34 billion to 1.36 billion dollars, representing growth of 36 to 38 percent. For oncology, we now expect revenue growth of approximately 30% and volume growth of approximately 50%.

Speaker #2: Our biopharma and data outlook is unchanged at low double-digit growth, supported by a recent strategic partnership and continued good progress across the companion diagnostic pipeline.

Speaker #2: The outlook reflects continued smart app adoption of Guardant 360 liquid, strong commercial execution, and the impact of recent product upgrades in Guardant 360 tissue as well as continued growth in Reveal across MRD and therapy monitoring.

Speaker #2: For screening, we are raising revenue guidance to a range of 218 million to 230 million dollars, and now expect 270,000 to 285,000 Shield tests.

Speaker #2: The higher outlook reflects strong demand and commercial execution, as well as greater confidence following ACS guideline inclusion and UnitedHealth Healthcare coverage, which becomes effective in August.

Speaker #2: Our biopharma and data outlook is unchanged at low double-digit growth, supported by recent strategic partnerships and continued good progress across the companion diagnostic pipeline.

Speaker #2: Our full-year non-gap gross margin outlook remains 64 to 65 percent. The range incorporates lower testing costs for Gardened 360 liquid and Shield in the second half, partially offset by product mix as Shield and Reveal volumes scale.

Speaker #2: For screening, we are raising revenue guidance to a range of 218 million to 230 million dollars, and now expect 270,000 to 285,000 Shield tests.

Speaker #2: The higher outlook reflects strong demand and commercial execution, as well as greater confidence following ACS guideline inclusion and UnitedHealthcare coverage, which becomes effective in August.

Speaker #2: We intend to continue to reinvest incremental screening gross profit to support commercial expansion. As a result, we now expect 2026 non-gap operating expenses of 1.08 billion to 1.1 billion dollars, representing growth of 20 to 22 percent compared with 2025.

Speaker #2: Our full-year non-GAAP gross margin outlook remains 64 to 65 percent. The range incorporates lower testing costs for Guardant360, LUNAR, and Shield in the second half, partially offset by product mix as Shield and Reveal volumes scale.

Speaker #2: We now expect full-year free cash flow burn of 195 to 205 million dollars, 10 million dollars above our prior outlook, and an improvement compared with 2025.

Speaker #2: We intend to continue to reinvest incremental screening gross profit to support commercial expansion. As a result, we now expect 2026 non-GAAP operating expenses of $1.08 billion to $1.1 billion, representing growth of 20% to 22% compared with 2025.

Speaker #2: As mentioned, this revision reflects capex investments to accelerate the expansion of Shield's lab capacity, supporting anticipated growth over the next several years. We continue to expect the rest of the business, excluding screening, to generate positive free cash flow in 2026, with year-over-year improvements in cash generation, and we remain committed to achieving company-wide cash flow breakeven by the end of 2027.

Speaker #2: We now expect full-year free cash flow burn of $195 to $205 million, $10 million above our prior outlook, and an improvement compared with 2025.

Speaker #2: As mentioned, this revision reflects CapEx investments to accelerate the expansion of Shield's lab capacity, supporting anticipated growth over the next several years. We continue to expect the rest of the business, excluding screening, to generate positive free cash flow in 2026, with year-over-year improvements in cash generation, and we remain committed to achieving company-wide cash flow break-even by the end of 2027.

Speaker #2: Turning to slide 24, several catalysts we discussed last quarter are now in hand. In oncology, the Novotec X transition is complete, and Gardened 360 liquid CDX is FDA approved.

Speaker #2: Our priorities are continued expansion of smart platform apps, the launch of Reveal Ultra, and broader Reveal reimbursement. The ESR1 monitoring launch remains contingent on FDA approval of Camizestrant.

Speaker #2: Turning to slide 24, several catalysts we discussed last quarter are now in hand. In oncology, the Novitec X transition is complete, and Guardant 360 liquid CDX is FDA approved.

Speaker #2: In biopharma and data, our priorities are to continue to advance CDX programs, broaden strategic partnerships, and scale Infinity AI. In screening, we obtained ACS guideline inclusion and are excited about the UnitedHealth Healthcare coverage, both of which will help broaden access and adoption of Shield.

Speaker #2: Our priorities are continued expansion of smart platform apps, the launch of Reveal Ultra, and broader Reveal reimbursement. The ESR1 monitoring launch remains contingent on FDA approval of Camizestrand.

Speaker #2: We're also expanding Shield internationally through our self-pay channel. To close, Q2 demonstrates the breadth of our growth and the progress we're making in driving efficiencies across our operations.

Speaker #2: In biopharma and data, our priorities are to continue to advance CDX programs, broaden strategic partnerships, and scale Infinity AI. In screening, we obtained ACS guideline inclusion and are excited about the UnitedHealth Healthcare coverage, both of which will help broaden access and adoption of Shield.

Speaker #2: We are investing in the areas with the greatest long-term potential while maintaining our commitment to cash flow breakeven. With that, we'll open the call for questions.

Speaker #1: We will now begin the question and answer session. We ask that you please limit yourself to one question. If you would like to ask a question, please press star 1 to raise your hand, and to withdraw your question, press star 1 again.

Speaker #2: We're also expanding Shield internationally through our self-pay channel. To close, Q2 demonstrates the breadth of our growth and the progress we're making in driving efficiencies across our operations.

Speaker #1: We ask you pick up your handset when asking a question to allow for optimum sound quality and, if muted locally, please remember to unmute your device.

Speaker #2: We are investing in the areas with the greatest long-term potential, while maintaining our commitment to cash flow break-even. With that, we'll open the call for questions.

Speaker #1: Please stand by while we compile the Q&A roster. Your first question comes from the line of Kyle Mixon with Canaccord. Your line is open.

Speaker #1: We will now begin the question and answer session. We ask that you please limit yourself to one question. If you would like to ask a question, please press star 1 to raise your hand, and to withdraw your question, press star 1 again.

Speaker #1: Please go ahead.

Speaker #3: Hey guys, thanks for the questions. Congrats on a great broad-based performance in the quarter. The sound screening, though, first, UnitedHealth Health and ACS, obviously opens the market up to these under-65-year-olds.

Speaker #1: We ask you pick up your handset when asking a question to allow for optimum sound quality and if muted locally, please remember to unmute your device.

Speaker #3: Could you elaborate on the near and the long-term ASP and the volume impact? I guess after August, the volume tailwind could be pretty material, but pricing hasn't been finalized, I assume, for these commercial plans.

Speaker #1: Please stand by while we compile the Q&A roster. Your first question comes from the line of Kyle Mixon with Canaccord. Your line is open.

Speaker #3: And just secondly, kind of quickly, like on USCSTF, with all this happening, what's your thoughts on this late August meeting? Do you still think a late 27 or early 28 time frame for inclusion there makes sense?

Speaker #1: Please go ahead.

Speaker #3: Hey guys, thanks for the questions. Congrats on a great broad-based performance in the quarter. The sound screening though, first, UnitedHealth Health and ACS obviously opens the market up to these under-65-year-olds.

Speaker #3: Thanks.

Speaker #4: Andrew, Kyle, obviously we are very excited about this recent development with both ACS and UnitedHealth Health coverage. As I mentioned, the preferred remarks actually now roughly 70 million lives are covered for Shield, 60 percent of the whole market.

Speaker #3: Could you elaborate on the near and the long-term AST and the volume impact? I guess after August, the volume tailwind could be pretty material, but pricing hasn't been finalized, I assume, for these commercial plans.

Speaker #3: And just secondly, kind of quickly, like on USCSTF, with all this happening, what's your thoughts on this late August meeting? Do you still think a late 27 or early 28 time frame for inclusion there makes sense?

Speaker #4: This UHG win could actually give us some interesting benefits, like we are excited to see how the rest of the year would play out.

Speaker #3: Thanks.

Speaker #4: It could be a tailwind for the volume. It would help us to strategically step by step build our commercial side of the volume, so not just 65 and above, but actually younger patients and make sure they get actually access to this breakthrough technology.

Speaker #4: Andrew, Kyle, obviously we are very excited about this recent development. We built ACS and UnitedHealth Health coverage, as I mentioned in the pre-priv remarks, actually now roughly 70 million lives are covered for Shield, 60 percent of the whole market.

Speaker #4: This UHG win could actually give us some interesting benefits, and we are excited to see how the rest of the year will play out.

Speaker #4: ASP is going to take some time, though. ASP, in order to see the impact, we need to obviously go through some kind of conversations with them, but also show the history of collection from them in order to be able to accrue some of the upside upfront.

Speaker #4: It could be a tailwind for the volume. It would help us to strategically, step by step, build our commercial side of the volume—not just 65 and above, but actually younger patients—and make sure they actually get access to this breakthrough technology.

Speaker #4: So on ASP side, we need to be more patient. USCSTF, it's our expectation is as it was before. So looks like new members are going to be in place.

Speaker #4: AST is going to take some time though, like AST in order to see the impact, we need to obviously go through some kind of conversations with them, but also show the history of collection from them in order to be able to accrue some of the upside upfront.

Speaker #4: Looks like the August meeting is going to happen, but in terms of our expectation, we are not changing anything. So we are monitoring to see what happens.

Speaker #4: And it's interesting as I mentioned, some of the payers, even before USCSTF, are engaging in conversations with us. And we'll see what happens.

Speaker #4: So, on the AST side, we need to be more patient. For the USCSTF, our expectation is as it was before. So, it looks like new members are going to be in place.

Speaker #1: Your next question comes from the line of Subu Nambi with Guggenheim. Your line is open. Please go ahead.

Speaker #4: Looks like the August meeting is going to happen, but in terms of our expectations, we are not changing anything. So, we are monitoring to see what happens, and it's interesting—as I mentioned, some of the payers, even before USPSTF, are engaging in conversations with us.

Speaker #5: Hey guys, thank you for taking my question. Congratulations on another record oncology volume and shield quarter. As we think about oncology volume guide, could you give us a puts and takes on the 50 percent guide raise?

Speaker #5: Is this largely from Reveal and metastatic stage? And how is per-patient testing cadence looking today? I know it's early. And looking to Q3, given the tough comp in G360, how should we think about G360 volume growth?

Speaker #4: And we'll see what happens.

Speaker #1: Your next question comes from the line of Subu Nambi with Guggenheim. Your line is open. Please go ahead.

Speaker #5: Hey guys, thank you for taking my question. Congratulations on another record oncology volume and Shield quarter. As we think about oncology volume guide, could you give us a good syntax on the 50 percent guide raise?

Speaker #5: And I know I'm tacking on multiple questions, but one question for you, Amira Lee. How did the UnitedHealth coverage come about? It was surprising to us.

Speaker #5: None of us had that in our 2026 bingo card. So how might that influence other private payer coverage in the absence of even USCSTF?

Speaker #5: Is this largely from Reveal and metastatic stage, and how is per patient testing cadence looking today? I know it's early. And looking to Q3, given the tough comp in Q3 '60, how should we think about G3 '60 volume growth?

Speaker #5: Thank you so much.

Speaker #4: Great. So Saria, thanks to both for the good question. Yeah, we're really excited about what we saw in the quarter in terms of oncology volumes.

Speaker #4: Obviously, that a tremendous sort of volume ramp that we saw, and it was really broad-based in terms of the beat we saw. Great volumes from 360 growing over 30 percent year over year.

Speaker #5: And I know I'm tacking on multiple questions, but one question for you, AmirAli. How did the UnitedHealth coverage come about? It was surprising to us.

Speaker #5: None of us had that in our 2026 bingo card. So, how might that influence other private payer coverage in the absence of even the US CSTF?

Speaker #4: Tissue continued to accelerate. And it was higher than obviously than 360. And then Reveal was also over 100 percent. And so I think all of them are really going to be contributing to sort of continued strong volume for the second half of the year.

Speaker #5: Thank you so much.

Speaker #4: So, sorry—thanks, Subu, for the good question. Yeah, we're really excited about what we saw in the quarter in terms of oncology volumes. Obviously, that's a tremendous sort of volume ramp that we saw, and it was really broad-based in terms of the beat we saw.

Speaker #4: And obviously, we have strong sort of comps for Q3 and Q4 for 360, but I think we're very confident that we can continue the momentum we're seeing at least in the first half of the year on all of the products going forward.

Speaker #4: Great volumes from 360, growing over 30 percent year over year. Tissue continued to accelerate, and it was higher, obviously, than 360. And then Reveal was also over 100 percent.

Speaker #4: And so I think all of them are really going to be contributing to sort of continued strong volume for the second half of the year.

Speaker #4: And so that we can hit that 50 percent mark that we guided to. I don't know if Mike wants to add.

Speaker #2: I mean, no, just to reassure you how many events I think our guide now of 50 percent full year oncology volume growth is incredibly strong.

Speaker #4: And obviously we have strong sort of comps for Q3 and Q4 for 360, but I think we're very confident that we can continue the momentum we're seeing at least in the first half of the year on all of the products going forward.

Speaker #2: So yeah, I mean, we have I think we have tough comps now every quarter. So we'll continue to manage that. But I think our guide again for Q3 and Q4 is implying very strong oncology volume growth.

Speaker #4: And so that we can hit that 50 percent mark that we guided to. I don't know if Mike wants to add?

Speaker #2: I mean, no, just to reassure you how many that I think our guide now of 50 percent full year oncology volume growth is incredibly strong.

Speaker #3: And regarding UnitedHealth

Speaker #4: Health, it was unexpected for us too. It was much sooner than what we thought. It's going to happen. Having said that, we have multi-year relationship with UnitedHealth because of our oncology products and coverages.

Speaker #2: So yeah, I mean, we have I think we have tough comps now every quarter. So we'll continue to manage that. But I think our guide again for Q3 and Q4 is implying very strong oncology volume growth.

Speaker #4: We have the relationship. And we had multi-year conversations with UnitedHealth about the value of the shield and what it could offer. There's also something in the payer landscape that nobody want to be first.

Speaker #3: And during UnitedHealth

Speaker #4: Health, it was unexpected for us too. It was much sooner than what we thought it's going to happen. Having said that, we have multi-year relationship with UnitedHealth because of our oncology products and coverages.

Speaker #4: Nobody want to be last. So again, still, we don't expect any major wins in short term by any other major payers. Having said that, again, nobody want to be last too.

Speaker #4: We have the relationship, and we had multi-year conversations with UnitedHealth about the value of Shield and what it could offer. There's also something in the payer landscape where nobody wants to be first, and nobody wants to be last.

Speaker #4: And we are excited with some of the conversations that we are having with some plans. We see what happens, what will happen.

Speaker #1: Your next question comes from the line of Puneet Sauda with Lyrinc. Your line is open. Please go ahead.

Speaker #4: So again, we still don't expect any major wins in the short term by any other major payers. Having said that, again, nobody wants to be last too, and we are excited with some of the conversations that we are having with some plans.

Speaker #2: Yeah, hi. Amira Lee and Mike, thanks for taking my questions. And again, congrats on this impressive growth that you're seeing in the core business as well as shield.

Speaker #2: Is there a way to sort of characterize this? I mean, as I've pointed out before, this is an assay that's being on the market.

Speaker #4: We see what happens, what will happen.

Speaker #1: Your next question comes from the line of Puneet Sauda with Lyrinc. Your line is open. Please go ahead.

Speaker #2: G360 has been on the market. You revamped it. It's been on the market for 10 years plus. And it's growing 30 percent. Now it's growing it appears to be growing even more faster.

Speaker #6: Yeah, hi. AmirAli and Mike, thanks for taking my questions. And again, congrats on this impressive growth that you're seeing in the core business as well as Shield.

Speaker #2: Are you portfolios growing faster? Sort of where are we in this S-curve of growth? And then on the shield side, Amira Lee, just wondering, how should I think how should we think about the drivers for upside?

Speaker #6: Is there a way to sort of characterize this? I mean, as I've pointed out before, this is an assay that's been on the market G3 60 has been on the market.

Speaker #2: Is it the sales reps? DTC ads? What are some of those? And how should we think about if there is any third and the fourth quarter sequential ramp growth that if you can provide on shield?

Speaker #6: You revamped it. It's been on the market for 10 years plus. And it's growing 30 percent. Now it's growing it appears to be growing even more faster.

Speaker #6: Are you portfolios growing faster? Sort of where are we in this S-curve of growth? And then on the Shield side, AmirAli, just wondering, how should I think how should we think about the drivers for upside?

Speaker #2: Thank you.

Speaker #4: Yeah, thanks for the question, Puneet. We're very excited about what we're seeing. And what we obviously built the product to and how advanced we believe it is compared to sort of the landscape right now and the liquid biopsy.

Speaker #6: Is it the sales reps DTC ads? What are some of those and how should we think about if there is any third and the fourth quarter sequential ramp growth that if you can provide on Shield?

Speaker #4: Market, it really is one of the most comprehensive tests out there. It's covers broadly all the genomic markers of relevance, but really the only test that has integrated genome-wide methylation coverage, which is really driving a lot of the, I think, really exciting sort of next-gen applications of liquid biopsy.

Speaker #6: Thank you.

Speaker #2: Yeah, thanks for the question, Puneet. We're very excited about what we're seeing, and it's what we obviously built the product for and how advanced we believe it is compared to the landscape right now in liquid biopsy.

Speaker #4: And frankly, I think we're just scratching the surface in terms of what's possible with this platform. And I think many physicians are just starting to get sort of the experience of using it with patients and it's when you get those hits when you find something that you couldn't find before, you find an option for a patient it takes time to sort of get those experiences.

Speaker #2: Market, it really is one of the most comprehensive tests out there. It's covers broadly all the genomic markers of relevance, but really the only test that has integrated genome-wide methylation coverage, which is really driving a lot of the, I think, really exciting sort of next-gen applications of liquid biopsy.

Speaker #4: And I think we're really leaning into it now that it's been on the market for a few quarters. And we're very excited about the pipeline in terms of other apps that we have in development that will be coming out soon.

Speaker #2: And frankly, I think we're just scratching the surface in terms of what's possible with this platform. And I think many physicians are just starting to get sort of the experience of using it with patients and it's when you get those hits when you find something that you couldn't find before, you find an option for a patient it takes time to sort of get those experiences.

Speaker #4: So we think this is something that we can continue to lean into not just for the sort of one test per patient era that we're in right now, but when we start thinking about patients using a liquid biopsy, a Guardant 360 test, at every progression.

Speaker #2: And I think we're really leaning into it now that it's been on the market for a few quarters. We're very excited about the pipeline, in terms of other apps we have in development, that will be coming out soon.

Speaker #4: And that's still not something we've leaned into. That's a big market multiplier. And why we believe we can continue to sort of lean in to this growth of 360 for years to come.

Speaker #2: So we think this is something that we can continue to lean into not just for the sort of one test per patient era that we're in right now, but when we start thinking about patients using a liquid biopsy, Guardant 360 test, at every progression.

Speaker #1: Your next question.

Speaker #3: Regarding there was something about shield quickly to answer that. The sequential growth of Q2 over Q1 was super strong for us, 22,000 step up.

Speaker #2: And that's still not something we've leaned into. That's a big market multiplier, and why we believe we can continue to sort of lean in to this growth of 360 for years to come.

Speaker #3: There were multiple factors that compounded at once. We launched this flexible promotion. We launched our DTC, we are adding to our field force. And there is some non-linear effects that we are seeing.

Speaker #1: Your next question.

Speaker #3: Regarding there was something about Shield quickly to answer that. The sequential growth of Q2 over Q1 was super strong for us, 22,000 step up.

Speaker #3: That the productivity of our reps have gone up in a very interesting way when we are doing the core promotion with Quest and we have our DTC in the air.

Speaker #3: There were multiple factors all combined in between Q2 and Q1. So we don't expect multiple new things all hitting at once in Q3. Having said that, we are very excited of what we can do in the second half.

Speaker #3: There were multiple factors that compounded at once. We launched this flexible promotion. We launched our DTC, we are adding to our field force. And there is some non-linear effects that we are seeing.

Speaker #3: The productivity of our reps has gone up in a very interesting way when we are doing the co-promotion with Quest and we have our DTC in the air.

Speaker #3: We increase our guide by 40,000 samples, which translates at the midpoint. The guide that we put out there sequential growth of 12,000 Q over Q.

Speaker #3: There were multiple factors all combined in between Q2 and Q1. So we don't expect multiple new things all hitting at once in Q3. Having said that, we are very excited of what we can do in the second half.

Speaker #3: We don't want to get ahead of our skis with the fantastic Q2 results that we have for the rest of the year. And we're very thoughtful.

Speaker #3: I think it's a very reasonable guide for the second half of the year for us.

Speaker #3: Like, we increased our guide by 40,000 samples, which translates, at the midpoint, the guide that we put out there, to sequential growth of 12,000 quarter-over-quarter.

Speaker #1: Your next question comes from the line of Mark Massaro with BTIG. Your line is open. Please go ahead.

Speaker #4: Hey, guys. Congratulations on another great quarter. Helmi, I know in the last couple of years, you've talked about how you'd like to sort of reframe how pricing the value of diagnostic tests in the industry.

Speaker #3: We don't want to get ahead of our skis with the fantastic Q2 results that we have for the rest of the year. And we're very thoughtful.

Speaker #3: I think it's a very reasonable guide for a second half of the year for us.

Speaker #4: The reason I'm asking this question is like Subaru said, the United coverage really caught everybody by surprise. So as we think about your ADLT rate of 1,495, how should we how are you thinking about negotiating with United?

Speaker #1: Your next question comes from the line of Mark Massaro with BTIG. Your line is open. Please go ahead.

Speaker #5: Hey guys, congratulations on another great quarter. Helmy, I know in the last couple of years, you've talked about how you'd like to sort of reframe how pricing the value of diagnostic tests in the industry.

Speaker #4: What is your appetite for a discount? And then you talked about how you're encouraged with other conversations with commercial payers. It would seem logical that other payers would probably follow, but I was curious if you could just speak to the importance of ACS and NCCN and to what extent those endorsements in some ways might de-risk USPSTF.

Speaker #5: The reason I'm asking this question is like Subaru said, the United coverage really caught everybody by surprise. So as we think about your ADLT rate of 1,495, how should we how are you thinking about negotiating with United?

Speaker #5: What is your appetite for a discount? And then you talked about how you're encouraged with other conversations with commercial payers. It would seem logical that other payers would probably follow, but I was curious if you could just speak to the importance of ACS and NCCN and to what extent those endorsements in some ways might de-risk USPFTS.

Speaker #5: And that's for Amira Lee, so let him answer that.

Speaker #3: Yes, so in terms of pricing negotiation, we just got the coverage. A lot of us go through that process and see what's going to happen.

Speaker #3: It's very typical in diagnostics, Medicare pricing is the center piece of conversations and our pricing is very transparent to everybody when they make it and the coverage decision.

Speaker #3: So what we'll see how it goes. In terms of de-risking, I think United Health decided to act before USPSTF and we are seeing some additional conversation with other payers.

Speaker #2: And that's for AmirAli, so let him answer that.

Speaker #3: Yes, in terms of pricing negotiation, like we just got the coverage so let us go through that process and see what's going to happen.

Speaker #3: It's very typical in diagnostics—Medicare pricing is the centerpiece of conversations, and our pricing is very transparent to everybody when they make a coverage decision.

Speaker #3: Definitely we are getting the attention United Health coverage decision is getting the attention by other people. Our progress in the field in terms of the impact we are showing is getting the attention.

Speaker #3: So what we'll see how it goes. In terms of de-risking, I think United Health decided to act before USPFTS and we are seeing some additional conversation with other payers.

Speaker #3: We have a scale team in managed care team that have all the connections and relationships and with a bunch of those people we have multi-year conversation about shield.

Speaker #3: But again, we'll see how it goes. We don't expect any major wind for the rest of the year. We haven't included anything in our guide in terms of additional wind.

Speaker #3: Definitely we are getting the attention United Health coverage decision is getting the attention by other people. Our progress in the field in terms of the impact we are showing is getting the attention and we have a scale team in managed care team that have all the connections and relationships and with a bunch of those people we have multi-year conversation about Shield.

Speaker #3: And we'll see how it goes.

Speaker #1: Your next question comes from the line of Dan Brennan with TD Cowan. Your line is open. Please go ahead.

Speaker #2: Great. Thank you.

Speaker #3: Thanks for the questions. Maybe I'll just have one on ADLT. So first off is kind of 8,500 plus or minus the right price, Amira Lee.

Speaker #3: But again, we'll see how it goes. We don't expect any major wind for the rest of the year. We haven't included anything in our guide in terms of additional wind.

Speaker #3: And we'll see how it goes.

Speaker #3: Excuse me, Helmi. When we did the math, we came up with about a 7% increase to revenues in '27, 20% in '28, just based upon the realized price that you'd be able to capture.

Speaker #1: Your next question comes from the line of Dan Brennan with TD Cowen. Your line is open. Please go ahead.

Speaker #3: So anything A you could share about whatever price you pick, like what type of MA in commercial realized price increases? What's a reasonable way to think about that?

Speaker #4: Great. Thank you.

Speaker #3: Thanks for the questions. Maybe I'll just have one on ADLT. So, first off, is kind of $8,500 plus or minus the right price, AmirAli?

Speaker #3: And then importantly, whatever the revenue impact is, can you just help us think through what the drop the rate will be? How much of that revenue upside would you plan to reinvest back in the business?

Speaker #3: Excuse me, Helmy. When we did the math, we came up with about a 7% increase to revenues in '27, 20% in '28, just based upon the realized price that you'd be able to capture.

Speaker #3: And how much of it will accrue to the pre-tax line? Thank you.

Speaker #3: So, anything you could share about whatever price you pick—like what type of MA and commercial realized price increases? What's a reasonable way to think about that?

Speaker #4: Yeah. No, I think we're going through the ADLT process now. We're expecting a price of 84.55. And so that will be an uplift from our current Medicare price of 5,000.

Speaker #3: And then importantly, whatever the revenue impact is, can you just help us think through what the drop the rate will be? Like how much of that revenue upside would you plan to reinvest back in the business and how much of it will accrue to the pre-tax line?

Speaker #3: Thank you.

Speaker #4: And then that would be immediate an immediate increase it'll take time for Medicare Advantage and commercial payers to sort of change the price in line with the new Medicare price.

Speaker #2: Yeah. No, I think we're going through the ADLT process now. We're expecting a price of 84.55. And so that will be an uplift from our current Medicare price of 5,000.

Speaker #4: And I think we've seen that in the past where Government 360 CDX got ADLT and ADLT pricing it can take sort of 12 to 24 months for that to flow through.

Speaker #2: And then that would be immediate an immediate increase it'll take time for Medicare Advantage and commercial payers to sort of change the price in line with the new Medicare price.

Speaker #4: So I would expect once we get that ADLT yeah, we'll see a nice uptick in overall ASB for Government 360. But then it should continue to improve over, again, the next sort of 12 to 18 months.

Speaker #2: And I think we've seen that in the past where Government 360 CDX got ADLT and ADLT pricing it can take sort of 12 to 24 months for that to flow through.

Speaker #4: Yeah. Investing the incremental gross profit. I think that's we've been sort of doing that over the past sort of 12, 18 months on the screening side of business.

Speaker #2: So I would expect once we get that ADLT, yeah, we'll see a nice uptick in overall ASB for Government 360, but then it should continue to improve again over the next sort of 12 to 18 months.

Speaker #4: And that's been allowing us to increase our investments specifically on the commercial side. I think we're oncology if and when we do get a higher ASP and incremental gross profit.

Speaker #4: We will allow some of that to drop down to the bottom line. I think we've said it many times, but we're very focused on getting to cash flow breakeven as quickly as possible.

Speaker #2: Yeah, investing the incremental gross profit. I think that's we've been sort of doing that over the past sort of 12, 18 months. On the screening side of business, and that's been allowing us to increase our investments specifically on the commercial side.

Speaker #4: And so that could give us the ability to accelerate our timeline, which is currently sort of Q4 2027. But we'd also want to take some of that gross profit and reinvest it back in the business.

Speaker #2: I think we're oncology if and when we do get a higher ASP and incremental gross profit, we will allow some of that to drop down to the bottom line.

Speaker #4: I mean, we continue to be a company of innovation. I think we want to continue to do that. But we would also on the oncology side of the business want to continue to invest on the commercial operations.

Speaker #2: I think we've said it many times, but we're very focused on getting to cash flow breakeven as quickly as possible. And so that could give us the ability to accelerate our timeline, which is currently sort of Q4 2027.

Speaker #4: So I think hopefully we'll be able to do both. And it'll start to we'll start to have a very nice P&L as and when that comes.

Speaker #2: But we'd also want to take some of that gross profit and reinvest it back in the business. I mean, we continue to be a company of innovation.

Speaker #2: I think we'd want to continue to do that. But we would also on the oncology side of the business want to continue to invest on the commercial operations.

Speaker #1: Your next question comes from the line of Daniel Markovitz with Evercore. Your line is now open. Please go ahead.

Speaker #5: Hey, guys. Congrats on the quarter and all the progress the last recent history as well. Thanks for taking my question. So when I look back at the investor day last year, you gave some helpful targets for 2028.

Speaker #2: So I think hopefully we'll be able to do both and it'll start to we'll start to have a very nice P&L as and when that comes.

Speaker #5: And there have been like I just said, lots of positive developments since then. So firstly, I just wanted to ask your high-level views on how things have trended and what it might mean for those targets.

Speaker #1: Your next question comes from the line of Daniel Markovitz with Evercore. Your line is now open. Please go ahead.

Speaker #5: And then double-clicking on G360, I'm tacking on to Dan's question. Now the table's set for ADLT, should we think about the ASP uplift with the new list price taking you up to closer to 5,000 rather than the prior target with closer to 3.3 thousand?

Speaker #5: Hey guys, congrats on the quarter and all the progress the last recent history as well. Thanks for taking my question. So when I look back at the investor day last year, you gave some helpful targets for 2028 and there have been like I just said, lots of positive developments since then.

Speaker #5: And then I also wanted lastly just more color from this ASP uplift if you drop that straight down to gross profit, it does imply really nice upside to the margins.

Speaker #5: So firstly, I just wanted to ask your high-level views on how things have trended and what it might mean for those targets. And then double-clicking on G360, I'm tacking on to Dan's question.

Speaker #5: And if profitability inflection, I just wanted to get more color on that and how you'd think about what to reinvest versus how much to drop down and whether the math is right in this really could be.

Speaker #5: Now the table's set for ADLT, should we think about the ASP uplift with the new list price taking you up to closer to 5,000 rather than the prior target with closer to 3.3 thousand?

Speaker #5: Meaningful profitability inflection. Thank you.

Speaker #5: And then I also wanted lastly just more color from this ASP uplift. If you drop that straight down to gross profit, it does imply really nice upside to the margins.

Speaker #4: Yeah. Yeah. I'll take that. Yeah. And again, just to sort of reiterate at our investor day, last year, we sort of increased our 2028 revenue target.

Speaker #5: And if profitability inflection— I just wanted to get more color on that and how you’d think about what to reinvest versus how much to drop down, and whether the math is right and this really could be a very meaningful profitability inflection.

Speaker #4: It would have previously been 2 billion. And we increased that to 2.2 billion. Which sort of inferred a growth rate over three years of just over 30%.

Speaker #5: Thank you.

Speaker #2: Yeah, yeah. I'll take that. Yeah. And again, just to sort of reiterate at our investor day last year, we sort of increased our 2028 revenue target.

Speaker #4: So I would say that so far, so good. I think we're doing very well against that target. Our current guidance now for the full year of '26 is 36 to 38%.

Speaker #2: It would have previously been $2 billion, and we increased that to $2.2 billion, which sort of inferred a growth rate over three years of just over 30%.

Speaker #4: So I think against what we need to do over that three-year period, we're doing very well. I don't think we're in a position to sort of change that target now, but I think where we are in the middle of '26 just gives us a lot more confidence that we can achieve that 2.2 billion.

Speaker #2: So I would say that so far so good. I think we're doing very well against that target. Our current guidance now for the full year of '26 is 36 to 38%.

Speaker #4: Yeah, I think the other question was related to the ADLT rate at 84.55. And would that lead to a Garden 360 ASP of around 5,000?

Speaker #2: So I think against what we need to do over that three-year period, we're doing very well. I don't think we're in a position to sort of change that target now, but I think where we are in the middle of '26 just gives us a lot more confidence that we can achieve that 2.2 billion.

Speaker #4: That's probably in the ballpark at on a sort of a long-term. I just mentioned on the last answer, it would probably take 12, 18, 24 months to sort of get to that level.

Speaker #2: Yeah, I think the other question was related to the ADLT rate at 84.55. And would that lead to a Garden 360 ASP of around 5,000?

Speaker #4: But realizing overall a sort of 60% of the Medicare rate, that's currently where we are. With Garden 360, so I think it's that sort of like 5,000 level is achievable.

Speaker #2: That's probably in the ballpark, on a sort of long-term basis. As I just mentioned in the last answer, it would probably take 12, 18, or 24 months to sort of get to that level.

Speaker #4: And yeah, I think basically on the profitability, the incremental gross profit and how we would manage that, I think talked about that on the last question with Dan.

Speaker #4: And again, I think it would be a mix of letting that drop down some of that drop down to the bottom line, hopefully accelerating our path to break even, but also reinvesting back in the business in innovation and on the commercial strength of the company.

Speaker #2: But realizing overall a sort of 60% of the Medicare rate, that's currently where we are. With Garden 360, so I think it's that sort of like 5,000 level is achievable.

Speaker #2: And yeah, I think basically on the profitability, the incremental gross profit and how we would manage that, I think we talked about that on the last question with Dan and again, I think it would be a mix of letting that drop down some of that drop down to the bottom line, hopefully accelerating our path to break even, but also reinvesting back in the business in innovation and on the commercial strength of the company.

Speaker #1: Your next question comes from the line of Evie. My apologies. Comes from the line of Casey Woodring with JP Morgan. Your line is open.

Speaker #1: Please go ahead.

Speaker #5: Great. Thank you for taking my questions. And yeah, congrats on the print. Howie, maybe can you give us a sense of how therapy monitoring volumes are tracking and how there's those are contributing to the greater than 100% volume growth and reveal.

Speaker #5: And any way to quantify or frame the revenue opportunity there once you turn on reimbursement for I/O and chemo? And then as a follow-up on G360, would just be curious to hear if you're seeing any material uplift in volumes that are driven by the FDA approval, if that's been a real needle mover for doctors that maybe have been on the sideline in terms of moving over from tissue.

Speaker #1: Your next question comes from the line of Evie. My apologies. Comes from the line of Casey Woodring with JP Morgan. Your line is open.

Speaker #1: Please go ahead.

Speaker #5: Great. Thank you for taking my questions. And yeah, congrats on the print. Howie, maybe can you give us a sense of how therapy monitoring volumes are tracking and how there's those are contributing to the greater than 100% volume growth and reveal and any way to quantify or frame the revenue opportunity there once you turn on reimbursement for I/O and chemo?

Speaker #5: Thank you.

Speaker #6: Yeah, great questions, Casey. We're very excited about what we're seeing with therapy monitoring. I mean, that said, we're seeing really good traction with MRD and with the reveal volumes.

Speaker #5: And then, as a follow-up on G360, I would just be curious to hear if you're seeing any material uplift in volumes that are driven by the FDA approval—if that's been a real needle-mover for doctors who maybe have been on the sidelines in terms of moving over from tissue.

Speaker #6: And but therapy monitoring, I think, is I would say maybe underappreciated opportunity in the market. This is, I think, the future of oncology in terms of moving from biopsies and scans to really just using blood quantitatively to both treat and monitor patient response to therapy.

Speaker #5: Thank you.

Speaker #4: Yeah, great questions, Casey. We're very excited about what we're seeing with therapy monitoring. I mean, that said, we're seeing really good traction with MRD and with the reveal volumes.

Speaker #6: So we're seeing very, very good uptake from our G360 orders who really want to sort of move into the future of precision medicine here.

Speaker #4: And but therapy monitoring, I think, is I would say maybe underappreciated opportunity in the market. This is, I think, the future of oncology in terms of moving from biopsies and scans to really just using blood quantitatively to both treat and monitor patient response to therapy.

Speaker #6: And yeah, and we think this is a great leading indicator for when we get some of the sort of reimbursement over the finish line, it's going to be a very, very strong business for us.

Speaker #6: If you think about it, there are a million late-stage patients it's a multi, multi-million sort of testing opportunity there just for therapy monitoring. If you think about monitoring those patients a couple of times during each course or each line, of therapy.

Speaker #4: So we're seeing very, very good uptake from our G360 orders, who really want to sort of move into the future of precision medicine here.

Speaker #6: And so I think it's could be I think nearly as big as maybe even the MRD opportunity testing point of view, at least in the active cancer patient segment.

Speaker #4: And yeah, we think this is a great leading indicator for when we get some of the reimbursement over the finish line. It's going to be a very, very strong business for us.

Speaker #4: If you think about it, there are a million late-stage patients. It's a multi, multi-million sort of testing opportunity there just for therapy monitoring. If you think about monitoring those patients a couple of times during each course or each line of therapy.

Speaker #6: And then in terms of FDA approval, it really happened sort of late in the quarter. So I think very early to sort of comment on that.

Speaker #6: And because we're doing a phased launch, yeah, it's having a positive impact, but nothing, I think, it won't be as big of an impact as when we finally sort of do a full launch once we get ADLT designation.

Speaker #4: And so I think it's could be, I think, nearly as big as maybe even the MRD opportunity. Testing point of view, at least in the active cancer patient segment.

Speaker #4: And then in terms of FDA approval, it really happened sort of late in the quarter. So I think very early to sort of comment on it.

Speaker #6: But certainly, we're seeing a lot of positive reception, a lot of excitement from physicians. And it's certainly something that we're going to lean into in the coming quarters.

Speaker #4: And because we're doing a phased launch, yeah, it's having a positive impact, but nothing, I think it won't be as big of an impact as when we finally sort of do a full launch once we get ADLT designation.

Speaker #1: Your next question comes from the line of Callum Titchmarsh with Morgan Stanley. Your line is open. Please go ahead.

Speaker #5: Yeah. Hey, guys. Thanks for taking the question. Maybe just one for Howie would be good to get a little more color on reveal ultra.

Speaker #4: But certainly we're seeing a lot of positive reception, a lot of excitement from physicians. And it's certainly something that we're going to lean into in the coming quarters.

Speaker #5: I guess perhaps just walk us through the indication roadmap. And then we'd love to just understand the commercial strategy in more detail as you go about capturing share there.

Speaker #5: And then for Amir Ali, just on the multi-cancer detection front, perhaps just walk us through the opt-in rates that you've been seeing on that.

Speaker #1: Your next question comes from the line of Callum Titchmarsh with Morgan Stanley. Your line is open. Please go ahead.

Speaker #5: And then how you're using the data that you've been generating from those tests. Thanks a lot.

Speaker #5: Yeah, hey, guys. Thanks for taking the question. Maybe just one for Helmy—it would be good to get a little more color on Reveal Ultra.

Speaker #4: Yeah. It's in terms of reveal ultra, it's highly competitive market. So I think we're keeping some things close to the chest here in terms of exactly how we're going to launch it and what indications.

Speaker #5: I guess perhaps just walk us through the indication roadmap. And then we'd love to just understand the commercial strategy in more detail as you go about capturing share there.

Speaker #5: And then for AmirAli, just on the multi-cancer detection front, perhaps just walk us through the opt-in rates that you've been seeing on that and then how you're using the data that you've been generating from those tests.

Speaker #4: But I can tell you that the development has gone really, really well in terms of the performance we're seeing. We're routinely hitting LOD levels of well below 1 parts per million.

Speaker #5: Thanks a lot.

Speaker #2: Yeah, in terms of Reveal Ultra, it's a highly competitive market, so I think we're keeping some things close to the chest here in terms of exactly how we're going to launch it and what indications.

Speaker #4: And in real samples, it's really exciting to see the potential there. I mean, that is detecting sort of tumors and early cancer at really unprecedented levels to be able to go that deep.

Speaker #2: But I can tell you that the development has gone really, really well in terms of the performance we're seeing. We're routinely hitting LOD levels of well below 1 parts per million.

Speaker #4: And it's going to be really, I think, we're very sensitive to how the product sort of fits with the rest of the portfolio. We want to really make sure that it's sort of seamless in terms of the connectivity between reveal, between Garden 360, and between our tissue products and so we're going to be very thoughtful in terms of how we launch it and which indications we launch it where.

Speaker #2: And in real samples, it's really exciting to see the potential there. I mean, that is detecting sort of tumors and early cancer at really unprecedented levels, to be able to go that deep.

Speaker #2: And it's going to be really, I think, we're very sensitive to how the product sort of fits with the rest of their portfolio. We want to really make sure that it's sort of seamless in terms of the connectivity between reveal, between Garden 360, and between our tissue products and so we're going to be very thoughtful in terms of how we launch it and which indications we launch it where.

Speaker #4: We believe we can sort of have the sort of greatest traction early on. And then also, I think, focused on thinking about the sort of reimbursement timelines there, the roadmap, some of the clinical validation as well.

Speaker #4: So that's a lot of the work we're doing there.

Speaker #5: Regarding Shield Multi-Cancer, data collection is going very well. Powered really by the attachment rate that remains very strong. And I mentioned that majority of physician ordering Shield now are opting in to receive the MCD results reports.

Speaker #2: We believe we can sort of have the greatest traction early on. Then we'll also, I think, focus on thinking about the reimbursement timelines there, the roadmap, and some of the clinical validation as well.

Speaker #5: So we are very happy with what we're seeing.

Speaker #2: So that's a lot of the work we're doing there.

Speaker #1: Your next question comes from the line of Dan Leonard with RBC Capital Markets. Your line is open. Please go ahead.

Speaker #5: Regarding Shield multi-cancer, data collection is going very well, powered really by the attachment rate that remains very strong. And I mentioned that the majority of physicians ordering Shield now are opting in to receive the MCD results reports.

Speaker #5: Thank you very much. So I have a follow-up question on the United Healthcare decision. To the degree that Amir Ali, to the degree that price sensitivity becomes a topic in that customer base, is there anything you could do to address or help with that, be a co-pays or otherwise, or is USPSTF really the solution to that?

Speaker #5: So, we are very happy with what we're seeing.

Speaker #1: Your next question comes from the line of Dan Leonard with RBC Capital Markets. Your line is open. Please go ahead.

Speaker #5: Just how you're thinking about that. So actually, we have to see what the United conversation would be around like the co-pay and the patient responsibility.

Speaker #5: Thank you very much. So I have a follow-up question on the United Healthcare decision. To the degree that AmirAli, to the degree that price sensitivity becomes a topic in that customer base, is there anything you could do to address or help with that to be a copays or otherwise?

Speaker #5: So we see how it goes. But obviously, post-USPSTF, if there is any co-pay that would go away. And about the rebates, I don't have any comments to share at this time.

Speaker #5: Or is USPSTF really the solution to that? Just how you're thinking about that.

Speaker #1: Your next question comes from the line of Mason Caracon with Stevens. Your line is open. Please go ahead. Please ensure you are unmuted locally and proceed with your question.

Speaker #3: So actually, we have to see what the United conversation would be around, like the copay and the patient responsibility. So we’ll see how it goes, but obviously, post-USPSTF, if there’s any copay, that would go away.

Speaker #3: And about the rebates, I don't have any comments to share at this time.

Speaker #1: Your next question comes from the line of Evi Kosloski with Goldman Sachs. Your line is open. Please go ahead.

Speaker #1: Your next question comes from the line of Mason Caracon with Stevens. Your line is open. Please go ahead. Please ensure you are unmuted locally and proceed with your question.

Speaker #6: Hi. Thank you for taking my questions. So given the acceleration that you saw in therapy monitoring indication for reveal, can you walk through some of the cross-selling benefit between therapy monitoring and therapy selection?

Speaker #6: And then any color you can provide on the Salesforce productivity related to this.

Speaker #4: Also, obviously, it's the same customer base in terms of the same oncologists that are ordering both tests and the two really sit hand in glove in the sense that you first test the patients to determine what therapy may be best for them.

Speaker #1: Your next question comes from the line of Evi Koslowski with Goldman Sachs. Your line is open. Please go ahead.

Speaker #6: Hi. Thank you for taking my questions. So, given the acceleration that you saw in the therapy monitoring indication for Reveal, can you walk through some of the cross-selling benefit between therapy monitoring and therapy selection?

Speaker #6: And then, any color you can provide on the Salesforce productivity related to this?

Speaker #4: And then you typically want to see how are they doing in that therapy. And so it's a nice one-two punch. In terms of how the products fit together and I think it is not only, I think, sort of a very strong introduction for us in terms of the utility of the product.

Speaker #2: Well, so obviously it's the same customer base in terms of the same oncologists that are ordering both tests and the two really sit hand in glove in the sense that you first test the patients to determine what therapy may be best for them.

Speaker #4: You can do some things that I think other products in the field can't do. But I think it also creates a nice sort of data stream for physicians where essentially you want to see the longitudinal view of every single patient through every line of treatment, through every progression, and so it's really, I think, leaning into this platformization concept that we talked about a couple of years ago introducing into the field.

Speaker #2: And then you typically want to see how they are doing in that therapy. And so it's a nice one-two punch in terms of how the products fit together, and I think it is not only, I think, sort of a very strong introduction for us in terms of the utility of the product.

Speaker #2: You can do some things that I think other products in the field can't do, but I think it also creates a nice sort of data stream for physicians, where essentially you want to see the longitudinal view of every single patient through every line of treatment, through every progression. So it's really, I think, leaning into this platformization concept that we talked about a couple of years ago introducing in the field, and this is really, I think, making that vision a reality now.

Speaker #4: And this is really, I think, making that vision a reality now.

Speaker #1: Your next question comes from the line of Paige Chamberlain with Wolf Research. Your line is now open. Please go ahead.

Speaker #7: Good afternoon, guys. Thank you so much for taking the question. I wanted to ask on the potential impact to volumes for the G360 tissue tests after the FDA approval of the liquid test.

Speaker #7: The thought being that reimbursement of the liquid tests under the MCD might give way to a volume acceleration for the tissue test. So I'm just wondering how you guys are thinking about that, and especially in light of the comments that I heard in the prep to remark about a phased rollout of the FDA-approved version of the test.

Speaker #1: Your next question comes from the line of Paige Chamberlain with Wolf Research. Your line is now open. Please go ahead.

Speaker #7: Good afternoon, guys. Thank you so much for taking the question. I wanted to ask about the potential impact to volumes for the G360 tissue tests after the FDA approval of the liquid test.

Speaker #7: So can we think about any volume good guys ahead of 80 LT pricing going into effect? Thank you so much.

Speaker #7: The thought being that reimbursement of the liquid tests under the NCD might give way to a volume acceleration for the tissue test. So I'm just wondering how you guys are thinking about that and especially in light of the comments that I heard in the prep to remark about a phased rollout of the FDA-approved version of the test.

Speaker #4: Yeah. No, that's a great question. I mean, we don't have, I would say, much baked in given the phased rollout, but we certainly are very excited for the potential for that once we get 80 LT designation and we have a sort of more complete rollout of the CDX.

Speaker #4: That said, I think we're very excited by the traction we're making with Garden 360 tissue. It's our second fastest growing product on the oncology side.

Speaker #7: So can we think about any volume good guys ahead of 80 LT pricing going into effect? Thank you so much.

Speaker #4: We saw acceleration this last quarter. And I think really starting to gain traction as more physicians realize some of the advantages that tissue has.

Speaker #2: Yeah, no, that's a great question. I mean, we don't have, I would say, much baked in, given the phased rollout, but we certainly are very excited for the potential for that once we get 80 LT designation and we have a sort of more complete rollout of the CDx.

Speaker #4: We're seeing a lot of standalone volume. In the field, we're really able to process much more challenging samples than a lot of the other tests out there.

Speaker #2: That said, I think we're very excited by the traction we're making with Garden 360 tissue. It's our second fastest growing product on the oncology side.

Speaker #4: And that piece of mind that performance advantage is really sort of standing on its own two feet and allowing us to really take a lot of share in the market.

Speaker #2: We saw acceleration this last quarter, and I think we're really starting to gain traction as more physicians realize some of the advantages that tissue has. We're also seeing a lot of standalone volume.

Speaker #4: Obviously, small numbers still, but very exciting to see the progress this last quarter. And for the remainder of the year.

Speaker #2: In the field, it really is able to process much more challenging samples than a lot of the other tests out there. And that piece of mind that performance advantage is really sort of standing on its own two feet and allowing us to really take a lot of share in the market.

Speaker #1: Your next question comes from the line of Brad Bowers with Mizuho. Your line is open. Please go ahead.

Speaker #5: Hey, thank you for the question. I actually wanted to hit on profitability obviously a positive FDA data point here lowering the COGS shield workflow.

Speaker #2: Obviously, small numbers still, but very exciting to see the progress this last—the remainder of the year.

Speaker #5: And I know overall we talked about kind of a million tests is kind of a break-in number, but the reason I'm asking is the way the streets modeling profitability is that it kind of flips pretty abruptly and severely, which I guess makes sense given a lot of the levers in the business.

Speaker #1: Your next question comes from the line of Brad Bowers with Mizuho. Your line is open. Please go ahead.

Speaker #5: But with everything firing off cylinders and the expectation kind of for ADLT pricing in the next year, just wanted to hear about how you're thinking about profit, whether there's anything else that's going to be pulled forward or if there's actually some type of EBITDA breakthrough over the next 12 months.

Speaker #5: Hey, thank you for the question. I actually wanted to hit on profitability. Obviously, a positive FTA data point here lowering the Cog Shield workflow.

Speaker #5: And I know overall we talked about kind of a million tests is kind of a break-in number, but the reason I'm asking is the way the streets modeling profitability is that it kind of flips pretty abruptly and severely, which I guess makes sense given a lot of the levers in the business.

Speaker #5: Thank you.

Speaker #8: Yeah. I can answer that. And really, when we're looking at sort of, well, adjusted EBITDA and profitability we almost talk about that in a similar breadth to free cash flow burn.

Speaker #5: But with everything firing on all cylinders and the expectation for ADLT pricing in the next year, I just wanted to hear about how you're thinking about profit—whether there's anything else that's going to be pulled forward, or if there’s actually some type of EBITDA breakthrough over the next 12 months.

Speaker #8: And we've been very sort of clear that getting to profitability, getting to cash flow break-even it's a key focus for the company. We're well on track to get to cash flow break-even by the end of 2027.

Speaker #5: Thank you.

Speaker #2: Yeah, I can answer that. And really, when we're looking at, sort of, well, adjusted EBITDA and profitability, we almost talk about that in a similar breath to free cash flow burn.

Speaker #8: And if you look at the business excluding screening, actually that business now is adjusted EBITDA positive. It's generating positive cash flow. And so we've achieved that with the rest of the business.

Speaker #2: And we've been very clear that getting to profitability, getting to cash flow breakeven, is a key focus for the company. We're well on track to get to cash flow breakeven by the end of 2027.

Speaker #8: We're continuing to make heavy investments to build out the commercial infrastructure on screening. And that's going to continue throughout '27. we do expect at a point in '27 that we'll reach some sort of critical mass in our commercial spending.

Speaker #2: And if you look at the business excluding screening, actually that business now is adjusted EBITDA positive. It's generating positive cash flow. And so we've achieved that with the rest of the business.

Speaker #2: We're continuing to make heavy investments to build out the commercial infrastructure on screening. And that's going to continue throughout 2027. As we continue to ramp up, we do expect at a point in 2027 that we'll reach some sort of critical mass in our commercial spending and we'll start to get a lot of leverage as the screening gross profit continues to increase and this reduction in the shield cost per test is going to help us get there.

Speaker #8: And we'll start to get a lot of leverage as the screening gross profit continues to increase. And this reduction in the shield cost per test is going to help us get that.

Speaker #8: And we should start to see screening start to ramp down in the burn sometime in '27. And that business itself getting to break-even in 2028.

Speaker #8: So we're well on track with what our expectations were. We're very focused on getting to profitability and cash. What could bring that forward? I think in the previous answer, we talked about getting ADLT designation for Garden 360 with an increase in the Medica price and potentially increasing Garden 360 ASP.

Speaker #2: And we should start to see screening begin to ramp down in the burn sometime in 2027, with that business itself getting to breakeven in 2028.

Speaker #8: If and when that happens, obviously that's going to, again, generate incremental bottom-line cash and profit for us. And so that could accelerate against that break-even and it could accelerate our sort of profitability ramp following that.

Speaker #2: So we're well on track with what our expectations were. We're very focused on getting to profitability and cash flow. What could bring that forward?

Speaker #2: I think in the previous answer, we talked about getting ADLT designation for Garden 360 with an increase in the Medica price and potentially increasing Garden 360 ASP.

Speaker #8: So again, I think we're tracking very nicely to our expectations.

Speaker #1: Your next question comes from the line of Taiko Peterson with Jefferies. Your line is open. Please go ahead.

Speaker #2: If and when that happens, obviously that's going to, again, generate incremental bottom-line cash and profit for us. And so that could accelerate against that breakeven and it could accelerate our sort of profitability ramp following that.

Speaker #5: Hey, team. This is Noah on for Taiko. Congrats on the quarter. I wanted to ask about Garden 360 tissue. Currently outgrowing the broader market in this application.

Speaker #2: So again, I think we're tracking very nicely to our expectations.

Speaker #5: I'm curious if you think these share gains are tied to maybe some of these concurrent testing trends of liquid that you've been talking about or an actual shift in provider preference.

Speaker #5: And then what does an underlying assumption look like for growth in this market? I want to go forward. Thanks.

Speaker #1: Your next question comes from the line of Taiko Peterson with Jefferies. Your line is open. Please go ahead.

Speaker #4: Yeah. No, I think right now, I think a lot of the growth is really sort of tissue standing on its own two feet. It's a product that can essentially utilize much smaller tissue samples.

Speaker #5: Hey, team, this is Noah on for Taiko. Congrats on the quarter. I wanted to ask about Guardant 360 tissue—currently outgrowing the broader market in this application.

Speaker #5: I'm curious if you think these share gains are tied to maybe some of these concurrent testing trends of liquid that you've been talking about or an actual shift in provider preference.

Speaker #4: And a lot of the tests that are out there that I think there's a lot of the sort of initial traction that we see with that product.

Speaker #5: And then what does an underlying assumption look like for growth in this market? I want to go forward. Thanks.

Speaker #4: But it's also one that is really one of the most comprehensive products on the market in a very large genomic panel, genome-wide methylation, full it's now a whole transcriptome as well.

Speaker #2: Yeah, no, I think right now, I think a lot of the growth is really sort of tissues standing on its own two feet. It's a product that can essentially utilize much smaller tissue samples than a lot of the tests that are out there, and I think there's a lot of the sort of initial traction that we see with that product.

Speaker #4: And so it's really one of the most comprehensive offerings on the market. We also recently rolled out a lot of the apps that we had in our liquid side on the tissue side as well.

Speaker #2: But it's also one that is really one of the most comprehensive products on the market, with a very large genomic panel, genome-wide methylation, and now a whole transcriptome as well.

Speaker #4: And so it's really benefiting from Infinity AI, the platform that we have in terms of developing a lot of these differentiating clinical applications. And so obviously this bodes well for that franchise in the future as concurrent testing does become more and more prevalent and more and more the standard of care for many tumor types.

Speaker #2: And so, it's really one of the most comprehensive offerings on the market. We also recently rolled out a lot of the apps that we had on our liquid side, on the tissue side as well.

Speaker #2: And so it's really benefiting from Infinity AI, the platform that we have in terms of developing a lot of these differentiating clinical applications. And so obviously this bodes well for that franchise in the future as concurrent testing does become more and more prevalent and more and more the standard of care for many tumor types.

Speaker #3: One more question, please, Ellen.

Speaker #1: Certainly. Our final question comes from Catherine Schultz with Baird. Your line is now open. Please go ahead.

Speaker #9: Hey, guys. Thanks for the questions. Maybe on Reveal, can you just talk through expectations on when you might hear back from MultiX on some of these indications, some of them are hitting close to the year mark.

Speaker #9: And then on the lower cog version of Shield, if we look at that PMA supplement, it looks like it kind of streamlines it to a methylation-only workflow and a removing fragmentomics and the somatic component.

Speaker #3: One more question, please, Helen.

Speaker #1: Certainly. Our final question comes from Catherine Schultz with Baird. Your line is now open. Please go ahead.

Speaker #9: So can you just talk through the development work that went into that and kind of how that might inform future iterations of the test?

Speaker #4: Hey guys, thanks for the questions. Maybe on Reveal, can you just talk through expectations on when you might hear back from Multi-X on some of these indications? Some of them are hitting close to the year mark.

Speaker #4: Yeah. In terms of Reveal, I mean, I can say that I think we're making progress on the submissions. And the packages we have there, I mean, certainly IO and breast are probably the closest to the finish line.

Speaker #4: And then on the lower COGS version of Shield, we look at that PMA supplement. It looks like it kind of streamlines it to a methylation-only workflow.

Speaker #4: We're going to remove fragmentomics and the somatic component. So can you just talk through the development work that went into that and kind of how that might inform future iterations of the test?

Speaker #4: I think we're hopeful that we can get at least one or both of them by end of this year. And obviously making some good progress on chemo as well.

Speaker #2: Yeah, in terms of Reveal, I mean, I can say that I think we're making progress on the submissions. And the packages we have there—I mean, certainly IO and breast are probably the closest to the finish line.

Speaker #4: Obviously taking a little bit longer than we would have liked, but I think we're very confident that we can get these over the finish line.

Speaker #4: And we have a number of other submissions that sort of are under development and in preparation. As soon as those get as soon as associated manuscripts get public, get published, we'll be submitting those as well.

Speaker #2: I think we're hopeful that we can get at least one or both of them by the end of this year. And obviously, we're making some good progress on chemo as well.

Speaker #4: So we have a lot of sort of balls in the air in terms of Reveal and we know that it's going to be a very, very big sort of franchise for us going forward as soon as we get some of these reimbursement wins.

Speaker #2: Obviously, it's taking a little bit longer than we would have liked, but I think we're very confident that we can get these over the finish line.

Speaker #2: And we have a number of other submissions that are sort of under development and in preparation. As soon as those— as soon as associated manuscripts get published, we'll be submitting those as well.

Speaker #2: And regarding the Shield workflow improvement, yeah, actually we are focused on methylation only, which the information is in the current version of Shield v1.

Speaker #2: The algorithm updates and multimodal Shield are generating kind of exciting pipeline activities for us in terms of hopefully continuing to see improvement in the Shield performance.

Speaker #2: So we have a lot of sort of balls in the air in terms of Reveal and we know that it's going to be a very, very big sort of franchise for us going forward as soon as we get some of these reimbursement wins.

Speaker #5: And regarding the Shield workflow improvement, yeah, actually, we are focused on methylation only, which—the information is in the current version of Shield v1.

Speaker #5: The algorithm updates and multimodal Shield are generating kind of exciting pipeline activities for us in terms of hopefully continuing to see improvement in the Shield performance.