Q3 2023 Guardant Health Inc Earnings Call

Speaker 1: Hello, everyone, and welcome to the Garden Health Q3 2023 Learning School. My name is D

Hello, everyone and welcome to the Guardant Health Q3, 2023 earnings call.

This is John I'll be your operator today.

Please make sure.

Okay.

Speaker 1: Your lines will be muted for the presentation part of the course. So if you want to ask a question, please make sure you press...

You just saw the presentation part.

Uh huh.

The clock says he wants to ask a question. Please make sure you do.

Yes.

Speaker 1: followed by one on your telephone keypad. I will now hand you over to your host, Carrie Mendez, investor relations from Garden Health.

Star followed by one on your telephone keypad.

I'll now hand, you over to your host Gary Mandel Investor Relations from Guardant health.

Please go ahead Kerry.

Speaker 2: Thank you. Earlier today, GARDEN Health released financial results for the quarter ended September 30, 2023. Joining me today from GARDEN are Helmi Altuki, co-CEO, Amir-Elie Talazaz, co-CEO, and Mike Bell, Chief Financial Officer.

Thank you.

Earlier today Guardant Health released financial results for the quarter ended September 32023.

Joining me today from garden or tell me, all chunky co CEO and nearly telecom co CEO and Mike Bell Chief Financial Officer.

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

Before we begin I'd like to remind you that during this call management will make forward looking statements within the meaning of federal Securities laws.

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: Additional information regarding material risks and uncertainties, as well as the reconciliation to the most directly comparable GAAP financial measures, are available in the press release garden issue today, as well as in our Form 10-K and other filings of the SEC.

There's no information regarding material risks and uncertainties as well as the reconciliation to the most directly comparable GAAP financial measures are available in the press release Guardant issued today as always in our Form 10-K, and other filings with the SEC.

Speaker 2: Gartner disclaims any intention or obligation to update or revise financial projections and forward-looking statements, whether because of new information, future events, or otherwise. The information in this conference call is accurate only as of the live broadcast. With that, I'd like to turn the call over to...

<unk> disclaims any intention or obligation to update or revise financial projections and forward looking statements are there because of new information future events or otherwise.

Information in this conference call is accurate only as of the live broadcast with that I'd like to turn the call over to help me.

Speaker 3: Thanks, Gary. Good afternoon and thank you for joining our third quarter 2023 earnings.

Thanks, Gary Good afternoon, and thank you for joining our third quarter 2023 earnings call.

Speaker 3: I will start off our call today with our top line results for the third quarter, and then go into more detail on our progress in therapy selection and MRD. I will then turn the call over to Amir Ali for an update on screening. And finally, Mike will provide a more detailed look at our financials and outlook for the remainder of 2023.

I'll start off our call today with our topline results for the third quarter and then go into more detail on our progress in therapy selection and then Mardi.

He will then turn the call over to Amir I'll leave for an update on screening and finally, Mike will provide a more detailed look at our financials and outlook for the remainder of 2023.

Speaker 3: Starting on slide three, Garden is a liquid biopsy leader in therapy selection with a strong pipeline of opportunities in MRD and screening. With our comprehensive suite of tests, we are transforming patient lives across the continuum of care. In early September , we hosted our inaugural investor day, a reshared a long-term vision for Garden. I encourage anyone who was unable to attend our investor day to access the replay on the investor's section of our website.

Starting on slide three garden is the liquid biopsy later in therapy selection with a strong pipeline of opportunities in MRV and screening with a comprehensive suite of cloud we are transforming patient lives across the continuum of care.

In early September we hosted our inaugural Investor Day, where we show you our long term vision for garden.

Anyone who wasn't able to attend our investor day to access the replay on the investors section of our website.

Speaker 3: It was a great opportunity to reflect on how far we have come over the past decade and look ahead to where we are going.

It was a great opportunity to reflect on how far we've come over the past decade, and look ahead to where we are going.

Speaker 3: We are just scratching the surface of what we believe is a massive opportunity in front of us. Our commitment to patients has always been at the heart of what we do. We look forward to continuing to grow our reach to impact more patient lives across the globe. Your supporthner, technology andConnect financially

We are just scratching the surface of what we believe is a massive opportunity in front of us our commitment to patients has always been at the heart of what we do we.

We look forward to continuing to grow our reach that more patient lives across the globe.

To demonstrate the impact of the protests.

Speaker 3: Start our call off today by sharing a patient story for our newest product, Pheel.

Got a call off today by sharing a patient story.

Louis crowded field.

Speaker 3: Earlier this year, a woman in her late 50s visited her primary care physician.

Earlier this year the women in their late <unk> visited or primary care physician.

Speaker 3: She was unscrewed for colorectal cancer and was resistant to receiving a colonoscopy.

On the screen for colorectal cancer and with resistant to receiving a colonoscopy.

Speaker 3: Her physician proposed a shield LVT test, which was added to her annual blood work. The shield test results reflected in abnormality, which led her physician to order a colonoscopy.

Physician proposed a shield LBP tests.

It was added to our annual blood work.

<unk> results reflected an abnormality, which letter position to order a colonoscopy.

Speaker 3: Those she had been hesitant of a colonoscopy at her initial visit, with this was all come shield, she piloted as getting the procedure done.

Those who had been hasnt been the colonoscopy out your initial visit when this was awesome shield you prioritize getting the procedure done.

Speaker 3: colonoscopy determined that she had stage 2 colorectal cancer. She started receiving chemotherapy right away, followed by surgery to remove a portion of her colon. After surgery and just a few months of treatment, she was healthy again.

Well not be determined that she likes stage III colorectal cancer.

She started receiving chemotherapy right away.

By surgery to remove a portion of the colon.

After surgery and just a few months of treatment she was healthy again.

Speaker 3: With a cancer caught early, she was able to participate in her sons wedding this past fall. This story is a powerful example of delivering an archimitment to increase co-electro screening compliance through the preference and ease of use in the position to look slow.

With their cancer Cod early she was able to participate in our son's wedding this past fall.

This story is a powerful example of delivering on our commitment to increase colorectal screening compliance through the preference and ease of use and acquisitions workflow.

Serving this station and the millions of others just like her who will face cancer. This year is why we exist.

Speaker 3: Serving this patient and the millions of others just like her will face cancer this year is why we exist. The results we shared today reflect the positive progress we are making in our mission to help at many of these patients that we...

The results we shared today reflect the positive progress we are making in our mission to help many of these patients that weekend.

Speaker 3: Turning the top line performance in slide four. We are pleased with our third quarter results with revenue growing another 22% this year to 143 million dollars.

Turning to topline performance in slide four we are pleased with our third quarter results with revenue growing another 22% this year to $143 million.

Speaker 3: This solid growth was driven by precision oncology revenue, which increased 31% in the quarter. We continue to see strength in our core therapy selection business with a number of tailwinds to drive growth over the long term.

This solid growth was driven by precision oncology revenue, which increased 31% in the quarter.

We continue to see strength in our core therapeutic vaccine business with a number of tailwind to drive growth over the long term.

Speaker 3: turning the slide five. We delivered strong growth across professional ecology with a record number of combined tests during the quarter. Clinical test volume during the third quarter reached 43,900 tests and increased of 35% from the prior year quarter. Clinical growth was driven by strong contributions from our key products supported by a robust commercial platform. For biopharma, we delivered 7,500 tests increasing 11% year over year.

Turning to slide five we delivered strong growth across decision oncology with a record number of combined set during the quarter clinical test volume during the third quarter with 43900 tests, an increase of 35% from the prior year quarter.

Clinical growth was driven by strong contributions from our key products supported by our robust commercial platform for Biopharma, we delivered 7500 tests, increasing 11% year over year.

Turning to slide six.

Speaker 3: Looking more closely at some of the highlights from the third quarter, we continue to benefit from tailwind scene earlier in the year with another quarter of solid year over year clinical volume growth across garden 360 and tissue net.

Looking more closely at some of the highlights from the third quarter, we continued to benefit from tailwind seen earlier in the year with another quarter of solid year over year clinical volume growth across garden 360 and tissue next.

Speaker 3: Notably nearly half of oncologists in the United States are now ordering a Garden 360 test every month, which highlights the strength of a core therapy selection business.

Notably nearly half scope oncologists in the United States are now ordering a garden 60 tests every month, which highlight the strength of our core therapy selection business.

Speaker 3: As is typical of mupti-privileves following the Garden T60 CDF approval for ESR1 mutation-positive patients, we saw spike in breast volumes in Q1 and Q2, fueled by tent-up damage.

As is typical with new approvals following the garden piece of <unk> approval for ESR, one mutation positive patients we saw a spike in breast volumes in Q1, and Q2 fueled by pent up demand in Q3, we had worked through that backlog and therefore had sequentially less breast cancer tests in Q3 than in Q2.

Speaker 3: In Q3, we had worked through this backlog and therefore, at sequentially less breast cancer tests in Q3 than in Q2. That said, we still had strong contributions from breast volume in the quarter, which increased significantly year over year. And we expected to see continued growth in this indicates.

That said, we still had strong contributions from breast volume in the quarter, which increased significantly year over year, and we expect to see continued growth in this indication.

Speaker 3: Our team remains focused on investing in a commercial infrastructure and providing the best customer experience.

Our team remains focused on investing in our commercial infrastructure and providing the best customer experience.

Speaker 3: Last week we announced the integration of our TDP test within Flat Irons on Klee M.

Last week, we announced the integration of our CGP tests with insider Iron Aqua EMR.

Speaker 3: With this underway, we are in the process of integrating the top three oncology EMR providers in the United States. These providers collectively represent approximately two-third of all oncology practices in the country, and these integrations are expected to reduce oncologists ordering time by 75.

With its underway we are in the process of integrating the top three oncology EMR providers in the United States. These providers collectively represented approximately two third of all oncology practices in the country and these integrations are expected to reduce oncologists ordering time by 75%.

Speaker 3: Notably, by the end of the year, we expect to be fully integrated in over 400 accounts. In addition to the customer experience benefit to the patient's health gains, we expect these partnerships to contribute to an uplift in ordering volume in 2024.

Notably by the end of the year, we expect to be fully integrated in over 400 accounts.

In addition to the customer experience benefits and efficiency gains. We expect these partnerships to contribute to an uplift in ordering volumes in 2024.

Speaker 3: We are also seeing growing contribution from MRD with another quarter of record bogging to garden reveals. We are on track to upgrade reveal with Smart Liquid Vibe T-Buy into this year.

We are also seeing growing contribution from MRV with another quarter of record volumes for garden revealed we are on track to upgrade reveal with smart liquid biopsy by end of this year.

Speaker 3: As we share Federal Investor Day, we are expanding into other geographies and are seeing an increasing contribution from labs globally.

As we shared at our Investor day, we are expanding into other geographies and are seeing an increasing contribution from labs globally.

Speaker 3: This quarter we saw good momentum, particularly in Europe , as the Royal Mars and garden-powered laboratory was awarded an expression of interest by the NHS to launch CGP for non-small-toe lung cancer in England, potentially making this technology accessible to thousands of patients across the country.

This quarter, we saw good momentum, particularly in Europe as the Royal Marsden Garden powered laboratory was awarded an expression of interest by the NHS.

CDP for non small cell lung cancer in England, potentially making this technology accessible to thousands of patients across the country.

Speaker 3: We are also making good progress in Asia with the recent launches of our assays for biocarbon use in China and of GARDEN 360 for clinical use in Japan.

We are also making good progress in Asia with the recent launches of our assays for Biopharma used in China and of Garden 360 preclinical use in Japan.

Speaker 3: In early September , Garden 360 CDFs received regulatory approval in Japan as a companion diagnostic to an HER2 for treatment of not small-to-lunk cancer patients with HER2 mutation.

In early September Garden, 360, <unk> received regulatory approval in Japan as a companion diagnostic to in her two for treatment of non small cell lung cancer patients with her two mutations.

Speaker 3: This follows the recent national reimburs from approval for Gartnery 60 CDX in Japan, which became affected at the end of July .

This call is the recent national reimbursement approval for Garden 360, <unk> in Japan, which became effective at the end of July.

Speaker 3: We are really excited about the opportunity in this market that Japan currently represents the largest expansion opportunity within our portfolio.

We are really excited about the opportunity in this market is Japan currently represents the largest expansion opportunity within our portfolio.

Speaker 3: While international revenues have historically been a relatively small portion of volumes, we expect significant growth from these core markets over the next year.

While international revenue has historically been a relatively small portion of that volume we expect significant growth from these core markets over the next year.

Speaker 3: Moving on to slide seven. In the third quarter, we continue to see breakthroughs and pay recovery that provide tailwinds for our clinical business in the near term, starting with therapy selection.

Moving on to slide seven.

In the third quarter, we continued to see breakthroughs in payer coverage that provide tailwind for our clinical business in the near term starting with therapy selection.

Speaker 3: We are starting to see the impact of the recent coverage when for Garden 360 with ASP is now towards the upper end of the 26th issue to $2,700 rain.

We're starting to see the impact of the recent coverage wins regarding 2016 with Asp's now towards the upper end of the 26, 15% to $2700 range. While this marks significant progress so far this year, our ASP will increase meaningfully more throughout the next few months.

Speaker 3: While this marks significant progress so far this year, our AST is going to be meaningfully more throughout the next few months.

Speaker 3: In late September , CMS proposed to cross-love garden through 60 LVT to a price of $5,000 as part of a rate setting process for reimbursement under the Medicare Clinical Rad P schedule next year.

In late September CMS proposed to crosswalk garden's <unk> to a price of $5000 as part of our rate setting process for reimbursement under the Medicare clinical lab fee schedule next year.

Speaker 3: If finalized, this will be a major milestone for gardens that will have a meaningful impact on our top and bottom line.

It's finalized this will be a major milestone for garden that'll have a meaningful impact in our top and bottom line Mike.

Speaker 3: Michael, share more about the uplift. We expect to see in our ASD shortlist.

Mike will share more about the uplift we expect to see in our ASC shortly.

Speaker 3: We are also working to expand private area in person with the ultimate goal of getting national biomarker testing coverage. We are seeing important and road made here. The date 13 states, most recently, California have enacted biomarker build into law that require providers to cover biomarker test.

We are also working to expand private payer reimbursement with the ultimate goal of getting national biomarker testing coverage, we're seeing important inroads made year to date.

13 States, most recently, California, Abenaki biomarker bill into law that requires providers to cover a biomarker testing.

Speaker 3: So actively, these enacted bills co-vernearly have to you as population.

Collectively these enacted bill cover nearly half the U S population.

Speaker 3: Two more Ohio and New York are pending. In many cases, these bills support private care coverage for both therapy selection and MRD. We'll continue to support efforts for the American Cancer Society and others to get these bills passed in more states to expand access to comprehensive biomarker testing through broad and private care coverage.

Tumor, Ohio, and New York are pending.

In many cases these goes towards private payer coverage for both therapy selection in MRV will.

We will continue to support efforts by the American cancer Society, and others to get these bills passed in more states to expand access to comprehensive biomarker testing through broadening private payer coverage.

Speaker 3: Lastly, we are continuing to make progress for the reimbursement for Tissue Next and reasonably surpassed 200 million covered lives.

Lastly, we are continuing to make progress with reimbursement for tissue neck, and recently surpassed 200 million covered lives.

Speaker 3: For MRD, we also receive coverage for Gardner Bill from the Geysinger Health Plan, providing coverage for more than half a million numbers.

For MLD, we also receive coverage for Gardner from the Geisinger health plan, providing coverage for more than half a million members.

Speaker 3: The test will be covered when used after surgery or curative treatment to inform physician decisions about adjuvant therapy and to monitor for disease progression recurrence or relapse.

The test will be covered when you use after surgery, a curative treatment to inform physician decisions about adjuvant therapy and to monitor for disease progression recurrence relapse.

Speaker 3: This build on the previous coverage we were seeing from Blue Cross and Blue Shield of Blue Vienna. We look forward to continuing to drive adoption or reveal an additionally in Birkenland.

This builds on the previous coverage, we received from Blue Cross Blue Shield of Louisiana.

We look forward to continuing to drive adoption of reveal and additional reimbursement win.

Speaker 3: Moving on to slide 8 to describe some recent data for the video.

Moving onto slide eight to discuss some recent data for the deal.

Speaker 3: In October , Pegasus in term data was released as a late breaking abstract at the Ezmo Congress.

In October Purgative interim data was released as a late breaking abstract at the ESMO Congress.

Speaker 3: Tagusis is a de-escalation clinical utility study for post-urgical liquid biopsyguide treatment of 135 stage 3 and high-risk stage 2 colorectal cancerization.

The Deescalation clinical utility study for post surgical liquid biopsy guidance treatment of 135 stage III and high risk stage III colorectal cancer patients.

Speaker 3: Initial results show that 34% of patients who were positive liquid by up to results after surgery had their cancer relapse, despite initiation of adjuvant sanitary.

Initial results showed that 34% of patients with a positive liquid biopsy results. After surgery had their cancer relapse, despite initiation of adjuvant chemotherapy.

Speaker 3: In addition, only 10% of patients with a negative result experienced the real-life.

In addition, only 10% of patients with a negative result experienced a relapse.

Speaker 3: Approximately 40% of patients converted from CTDNA positive to CTD-N-N-N-N after treatment to just the treatment Fx3 of chemotherapy to some patients.

Approximately 40% of patients converted from CDMA positive with CTV may negative after treatment, suggesting treatment efficacy of chemotherapy for some patients.

Speaker 3: These are also promising and suggest that our bill blood test and provided sensitive tools to help oncologists make informed treatment decisions that improve outcomes for their patients.

These results are promising and suggests that our reveal blood test and provide a sensitive tool to help oncologists make informed treatment decisions that improve outcomes for their patients.

Speaker 3: We expect to pull right out of this study in 2024. With that, I will now turn the caliber to a mural that will be the providing update on our screening business. Time's all made.

We expect full readout of this study in 2024.

With that I will now turn the call over to him to provide an update on our screening business.

Thanks, Amit.

Turning to slide nine.

Speaker 4: We are continuing to make advancements with our shield blood test as we pioneer a new category in the CRC screening mark.

We are continuing to make advanced speed, our shelf blood test as we are pioneering a new category and the CRC screening market.

Speaker 4: We submitted our pre-market approval application for Shield last March and our making steady progress with FDA review.

We submitted a premarket approval application of course share last March and are making steady progress with FDA review.

Speaker 4: We continue to expect that the approval and the launch of ShieldIVD in 2024.

Continuing to expect FDA approval and the launch of share by VEB in 2020 four.

Most recently, we concluded an girl mentioning our eclipse clinical study collectively range rolled over 45000 patients and biobank samples.

Speaker 4: Most recently we concluded in drill meant in our eclipse clinical study. Collectively, we enrolled over 45,000 patients and by bank these seven.

Speaker 4: This is a huge milestone and this bio-battery will really be a treasure for us for additional regulatory grade studies for future device upgrades.

A huge milestone and this <unk> really be a treasurer for us for additional regulatory great studies for future device upgrades.

Turning to slide 10.

Speaker 4: We are committed to innovation and continuous improvements by kills powered by efficient data generation.

We are cognizant to innovation and continuous improvement <unk> powered by efficient data generation.

Speaker 4: At our investor day in September , I shared some exciting new clinical data for the next generation version of SHIO.

At our Investor Day in September I shared some exciting new clinical data for the next generation version of shale.

Speaker 4: This data looks at the US-based cornoscopy screening cohort of about 2000 blinded cases collected prospectively from clinical sites and included screening negative adenomas and CRS.

This data looks at a U S based colonoscopy screening a cohort of about 2000 blinded cases collected prospectively from clinical sites and included screaming negative Adenomas crc's.

Speaker 4: Individuals from this cohort were tested with both version of the shield test.

Individuals from this cohort of our tested with both version of the shale test.

Speaker 4: The version used in our PMA Eclipse study, which will refer to as GLB1, and the next generation version, which will refer to as GLB2.

Diversion using our PMA Eclipse study, which we'll refer to us shale will be one.

And the next generation version, which will refer to as <unk>.

When we look at <unk> performance into perspective cohorts sensitivity was 84% with specificity of 90%.

Speaker 4: When we look at SHIELD V1's performance in this perspective cohort sensitivity was 84% with specificity of 90%.

Speaker 4: This was in line with the performance we saw from the same <expletive> and a clip school board, where sensitivity was 83% and specificity was 90%.

This was in line with the performance we saw from the same assay and eclipse cohort, whereas has such a history was 83% specificity was 90%.

Speaker 4: With the upgraded algorithm in V2, overall performance improved to 91% sensitivity and 91% specificity in this new prospective cohort.

With the upgraded algorithm going be to overall performance improved to 91% sensitivity at 91% specificity in this near perspective cohort.

Speaker 4: Looking at only early stage 1 or 2, sensitivity was 88% compared to 76% using the V1.

Looking at only earliest stage, one or two sensitivity was 88% compared to 76% using that'd be one assay.

Speaker 4: CRC-SANS-LTV-TN-SH3-N-TOR with built-test for 100% and SANS-LTV-TN-DTEC-N-Advanced at the NOMA-LOS-SIMMEL.

CRC sensitivity in stage, three and four with both test for 100%.

Sensitivity in detecting advanced adenoma was similar.

Speaker 4: This data gives us confidence that the clinical sensitivity of SHIELDv2 will be higher than the current SHIELDv1.

This data gives us confidence that the clinical sensitivity of Shelby two will be higher than the current shale where you want.

Speaker 4: We plan to conduct a regulatory great clinical study utilizing our already biobank samples.

We plan to conduct a regulatory great clinical study utilizing our already biobank samples that.

Speaker 4: that were collected during Eclipse study, to access the performance of shoes.

Were collected during eclipse study to assess the performance of Shelby Trail.

Speaker 4: Pending a successful readout, we will submit a supplemental PMA with the potential for approval in 2025.

Pending a successful readout, we will submit a supplemental PMA with the potential for approval in 2025.

Moving on to slide 11.

At the American College of Gastroenterology, or ACG annual meeting in October.

Speaker 4: At the American College of Gastroenterology, or ACGA, annual meeting in October , we presented some additional data about the real-world adherence rate with SHIELD and new insights from our health outcome model.

<unk> had some idea shall data about the real world that Trs radioed shale and new insights from our health outcome models.

Speaker 4: in addition, Kaiser Permanente Center for Health Research presented data on their experience with shield and the perception of blood-based testing for colorectal cancer screening from both patients and provides.

In addition, <unk>.

Or is there a fair amount that's a sensor for health research presented data on their experience with <unk> and the perception of a blood based testing for colorectal cancer screening from both patients and providers.

Speaker 4: The results of their randomized prospective trial were overwhelming we positive.

The results of the randomized prospective trial were overwhelmingly positive for sure.

Speaker 4: In this study, providers offer the shield blood test to randomize cohort of patients who have not completed it.

In this study providers offer this show blood tests to a randomized cohort of patients who have not compensated the fit test.

Speaker 4: patients who are offered shield were more than two times as likely to complete CRC screening compared to the patients receiving usual care.

Patients, who were offered shield, where more than two times as likely to comps CRC screening compared to their patients receiving unusual care.

Speaker 4: In addition, this study found that the patient and provider surveyed were enthusiastic about the potential for blood-based ERC screening tests to increase compliance.

In addition, the.

Study found that the patient and provider survey, we're enthusiastic about the potential for blood based CRC screening tests to increase compliance.

Last month, we reached an important milestone with the first part of the cash our blood based CRC screening testing and also of oncology.

Speaker 4: Last month, we reached an important milestone with the first publication of blood-based CRC screening tests in adults of oncology.

Speaker 4: This study was run on an early prototype of what is now shield and highlights how an accessible and convenient load test helps to increase effectiveness of sears.

This study was run on an early prototype of what is now shield and highlights how accessible like cognizant as lot test helps to increase the effectiveness of CRC screening.

We have always had a vision for blood based multi cancer screening.

Speaker 4: We have always had a vision for blood-based multi-cancer screen.

Speaker 4: Restarted with CRC has the first indication for shield because of the established pathways for FDA approval and reimbursement, which alone for broad acts.

He started with CRC has the first indication of course shale because of the established pathway for FDA approval and reimbursement, which allo for broad access.

Speaker 4: We are working to add lawn cancer as a second indication, followed by an expansion into another.

We are working to add lung cancer as a second indication followed by an expansion into other cancers.

Speaker 4: We are continuing to make good progress in enrollment into our morning cancer screening trial. Look forward to beginning enrollment for our interventional and set study next.

We are conscious to make good progress in enrollment and chart my cancer screening trial.

Look forward to beginning enrollment acquire interventional study next year.

Speaker 4: with that. I will now turn the call over to Mike for more detail on our financials. Thank you, Mirani. Starting with Gun.

With that I will now turn the call over to Mike for more detail on our financials.

Thanks, Emily Riley.

Starting with Gartner 360, ISP on slide 12.

Speaker 5: But tell me our line, we're starting to see the positive impact on garden 360 ASP from commercial paid coverage wins and have recently received confirmed and proposed medical price increases to garden 360 LVT.

So tell me outlined we're starting to see the positive impact on government receipts. The ISP from commercial coverage wins and have recently received confirmed and proposed Medicare price increases 2360 <unk> ODT.

In the third quarter, the governance, we seasonally AFP again trending towards the upper end of the 2650 to 2000 and $700 range. We saw in Q2.

Speaker 5: In the first quarter, the Gardner 3C is the ASP again, truly towards the upper end of the $2,650 to $2,700 range we've done Q2.

Speaker 5: At the start of October , we were informed by Muldiex that the Medicare price for Gardner 360 LBT has been increased from 3500 to a new Gapful rate of $3967 effective October 1, 2023.

At the start of October we were informed by multi X the Medicare price predominant III to LDP, there's been increased from 3500 to a new gas flow rate of $3967 effective October one 2023.

Speaker 5: Furthermore, in late September , CMS published its preliminary clinical lab fee schedule for 2024, which proposed that the Garden 360 LDP price would cost what to Garden 360 CDF?

Furthermore, in late September CMS published a preliminary clinical lab fee schedule for 2024.

It is proposed that the guidance, we see OTT price.

Regardless, we see Cvs.

Speaker 5: If this proposal is finalized, Medicare applies for $1,360 LVT will increase the $5,000 as of January 1, 2024.

If this proposal is finalized Medicare price began with <unk> will increase to $5000.

Annually, we want 2024.

Speaker 5: To put this price increase into context, many cup garden 360 LDT tests represent between 10 to 15% of our total garden 360 volume.

To put this price increase into context medica gotten 360 LDC tests.

Represent between 10% to 15% of our total Gardner 360 volume.

Speaker 5: As a result, the impacts of the Medicare price changes will be to increase the overall guard at 360 ASP. To be between $2,700 and $2,750 in Q4 2023, and then if the CMS proposed crosswalk pricing is implemented to $2,850 to $2,900 from January 1, 2024.

As a result.

Fact of the Medicare price changes will be to increase the overall data 360 <unk>.

To be between 2000 $702750 in Q4 2023.

And then if the CMS proposed crosswalk pricing is implemented since 2850 to $2900 from January one 2024.

With its headwinds we are seeing on coverage and pricing we are making very good progress towards the goal. We stated at our recent Investor day, although ultimately realizing an ASP of over 3000 votes for government 316.

Speaker 5: With the tailwinds we are seeing on Covrige and Pysings, we are making very good progress towards the bill we stated out out recent investor day of ultimately realizing an S.P. of over 3000 dollars for government treaty.

Speaker 5: Now, setting to our 2-3 financial results on slide 13.

Now turning to our Q3 financial results on slide 13.

Speaker 5: Feltz-en-Revenue for the first quarter of 2023, with 22 percent to $143.0 million, on person 117.4 million in the prior course.

Total revenue for the third quarter of 2023 grew 22% to 143 zero million.

Compared to $117 4 million in the prior year quarter.

Speaker 5: So total precision on co-edgy testing revenue for the third quarter was $133.4 million, increasing 31% compared to $102.1 million in the prior quarter.

Total precision oncology testing revenue for the third quarter was $133 4 million <unk>.

Increasing 31% compared to $102 1 million in the prior year quarter.

Speaker 5: As in previous courses, this increase was primarily driven by strong year of year growth in clinical and viaOrd preset reviewed in WYICGIT Image

As in previous quarters. This increase was primarily driven by strong year over year growth in clinical and Biopharma volumes.

Precision oncology revenue from clinical tests in the third quarter, so to $103 9 million.

Speaker 5: Position on code your revenue from clinical test in the third quarter. So to 103.9 million. Up 34% from 77.8 million for the prior course.

34% from $77 8 million for the prior year quarter.

Speaker 5: First what the clinical test for you was 43,900 and increased the 35% from the same period of the prior year.

First quarter clinical test volume was 43900, an increase of 35% from the same period of the prior year.

Speaker 5: The 3360 continues to be the main revving driver. We've continued to strong year over year growth.

<unk> thousand 360 continues to be the main revenue driver with continued strong year over year growth.

Speaker 5: As Henry mentioned, following the Gardner 365CDX approval for ASR1 mutation for sick patients with those spiking breast volumes in Q1 and Q2, feel by pen to demand.

As Hemi mentioned following the guidance of 360, <unk> approval put ESR one mutation positive patients.

So it's spiking breast volumes in Q1, and Q2 fueled by pent up demand.

Speaker 5: In Q3, we had worked through the SPAC logs and had therefore sequentially less breast cancer tasks in Q3, that in Q2. That said, we still have strong contributions from breast volume in the quarter, which increased significantly year-to-year. And we expect to see continued growth in the syndication.

In Q3, we had worked through this backlog and therefore sequentially less breast cancer tests in Q3 than in Q2.

We still had strong contributions from breast volume in the quarter, which increased significantly year over year, and we expect to see continued growth in this indication.

Speaker 5: Also note that the third quarter clinical revenue includes the payment of $3.6 million. We've seen from Medicare related to a successful appeal for claims dated between 2018 and 2020.

Also note that the third quarter clinical revenue includes a payment of $3 $6 million received from America related to a successful appeal claims dates between 2018 and 2020.

Speaker 5: This was one-time payment and there are no other outstanding claims that have yet to go through the deal.

This was a onetime payment and there are no other outstanding claims that have yet to go through this process.

Speaker 5: Excluding the $3.6 million payment, the blended clinical ASP was approximately $2,300, which is consistent with the previous quarter and in line with our expectations.

Excluding the $3 $6 million payment the blended clinical ASP was approximately $2300, which is consistent with the previous quarter and in line with our expectation.

Speaker 5: As a reminder, blended clinical AFP will continue to be influenced by both the volume mix between garland 360 tissue and extra real response, as well as the mix of overall clinical volume between the US and international.

As a reminder, blended clinical AFP will continue to be influenced by both the volume mix between guidance, we've safety tissue next review and response.

As well as the mix of overall clinical volume between the U S and internationally.

Speaker 5: Precision on code you're revenue from bio farm and testing the third quarter. So for $29.5 million of 22% from 24.2 million for the prior quarter.

Precision oncology revenue from Biopharma testing in the third quarter.

$29 $5 million of.

22% from $24 2 million for the prior year quarter.

Speaker 5: Firefarmer tends to be strong. With first quarter, it's also in the cost of nearly 7,500 tests, but 11% from the prior quarter. Firefarmer ASP in the third quarter was approximately $3,900, which was higher than both last quarter of 3,700 and the prior quarter at 3,600 due to the product mix.

Biopharma test volume was strong with third quarter totaling approximately 7500 tests up 11% from the prior year quarter.

Biopharma ASP in the third quarter was approximately $3900, which was higher than both last quarter with 3700 in the prior year quarter at 3600 due to the product mix.

Speaker 5: Development service with another MU in the third quarter shows the $9.6 million, down 5.7 million, our 37% from the prior year fourth.

Development services and other revenue in the third quarter totaled $9 6 million downside.

$5 7 million or 37% from the prior year quarter.

As we communicated last quarter. This was anticipated and was primarily due to the timing and amount of milestones related to our partnership agreements and companion diagnostic collaboration projects with Biopharma customers as well as a reduction in royalty revenue.

Speaker 5: As we communicated last quarter, this was anticipated from its primary review to the timing and amount of milestones related to our partnership agreements and companion diagnostic collaboration projects with biopharmacistomers, as well as a reduction in multi-reduction.

Speaker 5: Gross profit for the third quarter of 2023 was $85.4 million, compared to a gross profit of $76.9 million in the same period of the prior year.

Gross profit for the third quarter of 2023 with $85 4 million.

Compared to a gross profit of $76 9 million in the same period of the prior year.

Speaker 5: Gross margin was 60%, compared to 66% in the prior quarter.

Gross margin was 60% compared to 66% in the prior year quarter.

Speaker 5: For precision oncology, gross margin was 60% in the first quarter of 2023, which was slightly lower than 61% in Q3 2022, primarily due to changes in the product.

So precision oncology gross margin was 60% in the third quarter of 2023.

Which was slightly lower than 61% in Q3 2022, primarily due to changes in the product mix.

Speaker 5: Development Services and other growth margins was 59% in the third quarter of 2023, compared to 93% in Q3 2022.

Development services and other gross margin was 59% in the third quarter of 2023.

That's a 93% in Q3 2022.

Speaker 5: The change in margin was primarily due to the cost of processing shield LVT samples as part of our market development activities for which we are currently booking minimal revenue.

The change in margin was primarily due to the cost of processing shield LPT some pools as part of our market development activities for which we are currently booking minimal revenue.

Speaker 5: We continue to expect overall growth margins to be approximately 60% for the full year 2022.

We continue to expect overall gross margins to be approximately 60% for the full year of 2020.

Speaker 5: Operating expenses for the first quarter of 2023 were $199.0 million. A reduction of 22.5 million, 221.5 million in Q3 2022.

Operating expenses for the first quarter of 2023, the $199 7 million.

A reduction of $22 5 million compared to 221 5 million in Q3 2022.

Speaker 5: Net loss was $86.1 million or 73 cents per share for the third quarter of 2023 compared to $162.0 million or $1.68 per share in the third quarter of 2022.

Net loss was $86 1 million or <unk> 73 per share for the third quarter of 2023 compared to 162.0 million.

A $1 58 per share in the third quarter of 2022.

Speaker 5: The $75.9 million Euro-year reduction in net loss is primarily due to a $31.1 million year-of-year improvement in our loss from operations. A $29.9 million dollar positive change in unrealized games and losses recorded for our equity investment in Loonit and a $9.9 million increase in interest income. Moving on to non- GAAP financial ...

The $75 $9 million year over year reduction in net loss is primarily due to a $31 $1 million year over year improvement in our loss from operations of $29 9 million positive change in unrealized gains and losses recorded for our equity investment in Luna and the $9 9 million.

The increase in interest income.

Moving onto the non-GAAP financial measures on slide 14.

Speaker 5: Non-gap operating expenses were $177.3 million for the third quarter of 2023, a reduction of 23.3 million.

non-GAAP operating expenses were $177 3 million for the third quarter of 2023, a reduction of $23 2 million.

Speaker 5: compared to a $200.5 million in the Pi-Eqqq.

Compared to a $205 million.

In the prior year quarter.

non-GAAP net loss was $79 2 million or.

Speaker 5: Non-gap net loss with $79.2 million or $67 cents per share for the first quarter of 2023 from $132.8 million or $1.18 per share for the third quarter of 2022.

<unk> 67 per share for the third quarter of 2023 compared to $128 million or $1 18 per share for the third.

Quarter of 2022.

Speaker 5: Just to eat it that was a loss of $79.7 million in the third quarter of 2023, compared to a $112.8 million loss in the third quarter of 2022.

Adjusted EBITDA was a loss of $79 7 million in the third quarter of 2023.

To a $112 8 million loss in the third quarter of 2022.

Speaker 5: Three cashflow for the third quarter of 2023, with negative $80.2 million, comparison negative 99.9 million dollars in Q3 2022.

Free cash flow for the third quarter of 2023 was negative $82 million compared to negative $99 9 million in Q3 2022.

Speaker 5: We continue to make very good progress in managing our operating expenses in cash run. And we remain on track to achieve our goal of lowering our full year operating expenses compared to 2022, as well as reducing our free cash flow to approximately negative $350 million for the full year.

We continue to make very good progress in managing our operating expenses and cash burn and we remain on track to achieve our goal of lowering our full year operating expenses compared to 2022, as well as reducing our free cash flow to approximately negative $350 million for the full year.

Speaker 5: We ended the third quarter of 2023 with cash of approximately $1.2 billion.

We ended the third quarter of 2023 with cash of approximately $1 2 billion.

Speaker 5: As we laid out at our recent investment, we expect our talent cash will provide a runway to reach cashflow breakeven, which we are targeting in 2028. In addition, we're on track to achieve our targets of reaching cashflow breakeven and service elections by the end of this year, and of managing the annual screening cash bonus to be approximately $200 million.

As we laid out at our recent Investor day, we expect our current cash will provide a runway to reach cash flow breakeven, which we are targeting in 2028. In addition, we're on track to achieve our targets of reaching cash flow breakeven and therapy selection by the end of this year and just managing the annual screening cash burn to be approximately 200 million.

Speaker 5: We continue to expect that our annual cash grant for screening would be approximately 200 million over the next five years.

We continue to expect that our annual cash flow to screening will be approximately $20 million over the next five years.

Speaker 5: Now, setting to our look for the 4-year 2023 on slide 15, we're raising our 4-year 2023 revenue data and now expect revenue to be in a range of $553 to $556 million. Representing growth of approximately 23 to 24% compared to 2022.

Now turning to outlook for the full year 2023 on slide 15.

We are raising our full year 2023 revenue guidance and now expect revenue to be in the range of $553 million to $556 million.

Representing growth of approximately 23% to 24% compared to 2022.

This compares to our previous expectation of $545 million to $550 million.

Speaker 5: This compares to our previous expectations of 545 and 550 million dollars.

Speaker 5: Additionally, as has mentioned, we continue to expect 2023 operating expenses to be below full year 2022 and free cash loads to improve to be approximately negative $250 million in 2023.

Additionally, as just mentioned we continue to expect 2023 operating expenses to be below full year, 2022, and free cash flow to improve to be approximately negative $250 million in 2023.

Speaker 5: 10,000,000. Our long-term vision is to transform candidate instincts through cutting-edge technology, a focus on high impact opportunities and consistent execution. In the third quarter, we achieved our goal of 200 million COVID-19 lives per tissue next and remain on track to achieve the remainder of our stages milestones. At this point, we will now open the call to questions.

Turning to slide 17, our long term vision is to transform cancer diagnostics through cutting edge technology.

Focus on high impact opportunities and consistent execution.

In the third quarter, we achieved our goal of 200 million covered lives for tissue Matt.

We remain on track to achieve the remainder of our stated milestones.

At this point, we will now open the call to questions.

Okay.

Yes.

Speaker 1: Thank you. If you'd like to ask a question, please press star, followed by one on your telephone keypad. Please note that in the interest of time, you are respectfully asked to submit your intervention to one question per person and one follow-up only.

Thank you.

To ask a question. Please press star followed by one on your telephone keypad.

Please note that in the interest of time.

Great.

Thank you to one question per person.

And one follow up.

Speaker 1: The first question we have comes from Persia 7, a Morgan Stanley .

The first question we have.

Comes from Kasha.

Hi.

From Morgan Stanley. Please go ahead.

Speaker 6: Hey guys, good evening and thanks for the time here. Help me, Mike. Thanks for the color on the G360 ASP here. Just had a couple of quick follow-ups as my opener. Where do you anticipate that LED T versus CDX mix settling out following the change? And how should we think about the impact of the unique CPT code on the private parasite of things?

Hey, guys good evening.

Thanks for the time here.

Hi, Mike Thanks for the color on the <unk> hundred 60, <unk> just got a couple of quick follow ups is my <unk>, where do you anticipate that <unk> versus <unk> mix settling out following the change and how should we think about the impact of the unique CPT code on the private payer side of things.

Yes.

Speaker 5: Yeah, I think I can take that. What we've seen over the past 12-18 months is...

Yes.

I can take that.

Yes, what we've seen over the past.

12 18 months.

Speaker 5: You know, slowly the waiting between LDT and CDX has sort of moved more towards the CDX. So it's, I think it's fair to say that it's just over 50% on the CDX side. And so we're not really anticipating that this change in pricing is really gonna change that makes what we've seen really driving the change in mix is the...

Slowly the weighting between <unk> sort of moved more towards the CTX. So.

I think it's fair to say that.

Its just over 50% on the CDN side.

We're not really anticipating that this change in pricing is really going to.

Change that makes what we've said and really driving the change in mix as the seed.

Speaker 5: CDX approval that we've been getting over the last 18 months or longer. So, yeah, I don't think that the price impact will change that much.

<unk> approvals that we've been getting over the last 18 months or so.

Yes, I don't think the price impact.

We will change will change that much I'm sorry, the second part of the question.

Speaker 6: That was just on the private payers side of things.

Unique code.

Just on the private payer side of things yes.

Speaker 5: Now I think we think that's also be a positive. You know, what we sort of talked about with that increase in ASP is purely the medical impact.

Yeah.

I think we think that's also be a positive what we sort of talked about with that increase in ASP.

It's purely the.

Medicare impact and so I think there is potential.

Speaker 5: And so I think that's potential, additional improvements to the ASP, one from medical advantage.

Additional improvements to the ISP one from Medicare advantage.

Speaker 5: And so we think, you know, that's that will definitely help. But yeah, having a unique CPT code, it's gonna make the processing simpler for the private pairs. They'll have a medical list price to match against what they're paying as well. And so we think potentially it could make the system, well, take some friction out the system.

And so we think that that will definitely help but we are having.

Unique CPT code, it's going to make the processing simpler for the private payers.

America list price too.

To match against what they are paying as well and so we think potentially it could make the system, but it takes some friction out of the system made the pricing more transparent and could have a could have a positive impact. So we have not baked that into.

Speaker 5: made the pricing more transparent and could have a positive impact. So we've not thanked that into our ASP projections yet, but so we'll see how that goes next year.

ASP projections, yet, but so we'll see how that goes next year.

Yes.

Speaker 7: Got it. And then one quick follow up on Tagusus.

Got it and then one quick follow up on <unk>.

Speaker 6: I mean, can you help us contextualize the significance of that readout for us? Sounds like, you know, of that 10% of patients who experienced a relapse in the study, is that level sufficiently low enough to get physicians comfortable with de-escalation following a negative MRD result just based upon, you know, your physician conversation so far? And given that this was the older version of the essay, how do we read through the results to the commercially available version?

Can you help us contextualize the significance of that readout for us it.

It sounds like 10% of patients who experienced a relapse and the study is that level sufficiently low enough to get physicians comfortable with be escalation. Following a negative or Marty result, just based upon your physician conversations so far and given that this was the older version of the assay how do we.

Read through the results to the commercially available version.

Yes.

Speaker 8: Yeah, I know. So I think this is very positive in multiple aspects of the fact that this potentially highlights that you can spare patients, these high toxicity, adjuvant chemotherapy. And this is really a

I think this is very positive in multiple aspects and the fact that.

This potentially highlights that you can spare patients these high toxicity.

Adjuvant chemotherapy and.

And this is really a.

A sort of target that investor.

Speaker 8: a sort of target that the investigators said that they felt would move the standard of care for those patients forward and the fact that we met the sort of interim endpoints and I think it's really exciting and I think we're really looking forward to the full readout of this trial sometime in 2024.

Investigators that they felt.

Would move the standard of care for those patients forward and the fact that.

We met the sort of interim.

Endpoints.

And.

I think it is really exciting and so I think we're really looking forward to the full readout of this trial.

Sometime in 2024.

Speaker 8: in terms of how this reads through on to a current version of reveal and future version.

In terms of how this rates through loan too.

Current aversion of reveal in future versions.

Speaker 8: We see essentially improvements across the board in terms of sensitivity and specificity. And so clearly, if you're using an even better assize, then one here, the results should be even better. So we think this boat is very well in terms of being able to translate these results to our future versions of that.

We see essentially.

<unk> across the board in terms of sensitivity and specificity and so.

Clearly, if youre using and even better assays and doesn't want to hear the results should be even better. So we think this bodes very well in terms of being able to translate these results too.

Future versions of that.

Speaker 1: Thank you. We will take our next question from Dan Ariad from Steve Little. Take your hand.

Thank you we will take our next question from Dan Arias from Stifel. Please go ahead.

Hey, guys. Thanks for the questions Mike on just the clinical volumes for the quarter and for the year of 44000, or so for the quarter, which I think is up about 1% sequentially.

Speaker 9: Thanks for the questions. Mike, just the clinical volumes for the quarter and for the year, 44,000 or so for the quarter, which I think is up about 1% sequentially. Do you still think you finished the year with high 30s or low 40s growth as a target for 2023? That doesn't apply a step up in four keys, so just checking this view with the right way to model the full year is.

Thank you finished the year with high <unk> or low <unk> growth as a target.

FERC for 2023 that does imply a step up in <unk>. So just checking to see what the right way to model the four years.

Speaker 5: Yeah, I think yesterday we're still over 40% every year on clinical or even growth. And yeah, for the full year, high service is what the guidance implies. So we're still very confident that we'll see sequential left in Q4 and very strong year for the full year.

Yes.

I think.

Yesterday, we were asked to do so over 40% year over year volume growth.

For the full year, Yes, Hi, Hi studies is sort of the guidance.

This implies.

So we're yes, we're still very confident that we'll see.

Sequential uplift in Q4, and you have very strong year over year for the full year.

Speaker 9: Okay, and then, Amira Lee, on shield, as we close in on the end of the year here, wondering if you just, you might be willing to dial in, you're working assumption on a commercial launch time for 2024. And then just kind of expanding on some of your comments that you made at the investor day. It sounds like the USPSPS data review process could start next year for parts of the process anyway. And you just add some color to...

Okay, and then the merrily.

On shield as we close in on the end of the year here I'm wondering if you just you might be willing to dial in your working assumption on our commercial launch time for 2024, and then just kind of expanding on some of your comments that you made at the Investor day. It sounds like the USPS TF data review process could start next year for parts of the process.

Anyway and.

Can you just add some color too.

Speaker 9: The thought around having the likelihood of V2 get a look from the USPSTF as a part of that cycle. And then what that might mean if that doesn't happen and you have V1 being considered by the USPSTF, but V2 being the assay that presumably you feel better about going to Mark.

The thought around having the likelihood of <unk> to get a look from the USPS TF as a part of that cycle and then what that might mean.

That doesn't happen then you have the one being considered by the USPS TF <unk> to being the assay that presumably you feel better about going to market with.

Speaker 4: Yes, sure. So in terms of the reviews, I kill, as I mentioned, the preferred remarks we continue to see who progress, steady progress in the reviews, I kill, and continue to expect approval on launch of Shield IDB in 2024.

Yes, sure. So in terms of the review cycle as I mentioned in the prepared remarks, we continue to see good progress steady progress in their review cycle.

Content to expect approval and launch of shield IBD in 2024.

Regarding the cycles for USPS TF.

Speaker 4: regarding this side kills for uspspf.

Speaker 4: Yes, for 26 guideline inclusion, typically they start the data review a couple years before we expect that review starts sometime in the middle of 24 to say kind of half of 24 and then you know, conclude with a recommendation updates in 2026.

Yes for 'twenty six guideline inclusion typically they start the data review.

A couple of years before we expect that review started sometime in the 'twenty four to say kind of half of 'twenty four.

And then conclude with every commendation updates in 2026.

Speaker 4: Regarding shield V1 and V2 and guideline inclusion.

Regarding <unk> guideline inclusion.

Speaker 4: I continue to believe SHIELD V1 with the performances that be reported as long as we can get FDA approval for it. That hopefully we will, would get into the guidelines. And once SHIELD as a blood-based chlorrectal cancer screening branded by SHIELD goes into the guidelines.

Hi, conscientious believe shield, we want with the performance that we reported it as long as we can get FDA approval for it that hopefully we will.

Would get into the guidelines and.

Once shield as a.

Blood based colorectal cancer screening branded by shield goes into the guidelines future upgrades and updates to that test.

Speaker 4: future upgrades and updates to that test. It's kind of a continued market as shield, so I don't believe that we need to go through the cycle of USB-SDF in order to get the benefit of the commercial payer coverage that shield would have. So once the shield we want goes through that process.

It's going to continue.

Market as Sheila So I don't believe that we need to go through a cycle of USPS TF in order to get the benefit of the commercial payer coverage that shield would have so once the shelves. We wont go through that process. All the future versions as long as they are better than shield I expect them to be grandfathered.

Speaker 4: all the future versions as long as they are better than she'll. I expect them to be grandfathered in similar to what we experienced with other products. You know, that we upgraded them and the coverage policies continue to.

And then similar to what we experienced with other products.

We upgraded them and their coverage policies continue to stay in place.

Speaker 1: The next question comes from Mark Masaro from the BTI gene. Take a hand.

The next question comes from Mark Massaro from <unk>. Please go ahead.

Hey, guys. Congrats on a strong quarter I guess the first one is for helping me it's.

Speaker 10: Hey guys, congrats on a strong quarter. I guess the first one is for Helmi. It's encouraging to see Guy Zinger and...

It's encouraging to see guys linger and Blue Cross Blue Shield of Louisiana come on for reveal MRV.

Speaker 10: What other types of conversations are you having with other payers? I know that MRD is not yet included in NCCN guidelines, so I'd be curious to hear your thoughts on when you think MRD testing can be included in NCCN guidelines.

Curious what other types of conversations are you having with other payers I know that <unk> is not yet included in NCC and guidelines. So I'd be curious to hear your thoughts on when you think.

MRV testing can be included in <unk> guidelines and how those conversations with other payers are trending at this time.

Speaker 10: and how those conversations with other payers are trending.

Speaker 8: Yeah, great question, Mike Mark. I would say that, you know, obviously with 360 CDX, we have over 300 million covered lives. So we have a very strong managed care team that has relationships with many of the plans out there. And so we don't, I think those conversations are ongoing, we're continuing to make very good progress that I think with many plans.

Yes, great question. Thanks, Mark.

I would say that.

It was 360 <unk>.

Over 300 million covered lives and so we have a very.

Strong managed care team is it relationships with many of the plans out there.

And so I think those conversations are ongoing we're continuing to make very good progress I think with many plans.

Speaker 8: And I would say that the state biomarker bills are certainly a tailwind catalyst in terms of

And I would say that the state biomarker bills are certainly a tailwind.

In catalysts in terms of getting us too.

Speaker 8: coverage sooner rather than later. I think that's why I highlighted that now over half the US population is covered in a state that has one of these biomarker bills. And we obviously have.

Coverage sooner rather than later I think that's why I highlighted that now over half the U S population is covered in our state.

That has one of these biomarker bills and we obviously of New York, and Ohio, and hopefully some other states down the Pike. So we see this as a very important structural change in terms of how cancer tests are reimbursed, but if you have Medicare and your earliest stage biomarker bills.

Speaker 8: New York and Ohio and the others stays down the pike. So we see this as a very important structural change in terms of how cancer tests are reimbursed. But if you have Medicare and you have these state biomarker bills, you essentially have a really nice glide path in many states towards

Essentially you have a really nice glide path.

Many states towards full coverage, which is really going to I think up and what do we think about cancer diagnostics.

Speaker 8: It was really going to, I think, up and what we think about cancer diagnosis and the entire industry for years to come. So this is...

Entire industry for years to come. So this is very big move and one that bodes well for <unk>.

Speaker 8: very big move and one that votes well for MRT and potentially for other tests.

Potentially for other tests that we bring to market in the cancer biomarker testing space empty same guidelines I think utility data is what's typically are required I think this will be.

Speaker 8: that we bring to marketing the cancer by a market testing space.

Speaker 8: MCC and guidelines, I think utility data is what's typically required, I think, Pegasus who, you know, be sort of...

Be a sort of positive.

Tom.

Piece of evidence.

Further further bolsters the case for <unk> testing.

But there may need to be some additional readouts from the clinical utility perspective, before we see guidelines change.

Speaker 11: Excellent. And then my second question, the clinical volume growth of 35% was strong in the quarter. Is there any way you could break out the volume growth for me, their tissue next or reveal? And then as we're thinking about 2024, I would love to get your your latest thoughts on to what extent the integration with the EMR providers can help accelerate ordering either from 360 reveal or other tests. It helps the yolk stop taking overient subscribing and really ?kmother is going to even continue the replacement so when you reach out you will get your first aid control.

Excellent and then my second question.

Clinical volume growth of 35% was strong in the quarter.

Is there any way you could break out the volume growth from either tissue next or reveal and then as we're thinking about 2024 I would love to get your latest thoughts on to what extent the integration with the EMR providers can help accelerate ordering either from $3 16 reveal or other tests.

Let me start with the second half.

The first one.

This is typically.

Speaker 8: You know, a huge uplift when you are able to integrate visually with providers in terms of how they practice medicine and how they order their battery of tests and procedures and being able to.

Huge uplift when you are able to integrate digitally.

With providers in terms of how they practice medicine in how they order their battery of tests and procedures and being able to.

Speaker 8: Really go a long way this year and hopefully next year in terms of integrating with most of the US oncology market. We think is going to be an additional growth tribe where we're doing things at the large group practice level, account levels, as we said, level 400, counter integrated this year. And so there's going to be a lot of top down work.

Really go a long way this year and hopefully next year in terms of integrating with most of the U S. Oncology market. We think is going to be an additional growth driver. We're doing things at the large group practice level account levels as we say we will have over 400 accounts integrated this year.

So theres going to be a lot of top down work.

Speaker 8: that we're embarking on, especially in the community type centers, that we think will allow us to essentially embark on next stage of growth, not just for the 360, but for all our oncology brothers.

There were embarking on especially in the community type centers.

We think will allow us to essentially embark on the next stage of growth not just for the 360, but.

For all of our oncology products.

Speaker 8: Again, on the volume without breaking down.

Yes.

Volumes without breaking down into specific numbers, but.

Speaker 8: but both through review and tissue next year of year growth was both very strong. I think in previous quarters, I can previous quarter Q2 both were year of year growth was over 100%. Maybe both are slightly lower than 100% year of year growth in Q3, but

Both both.

Yes.

Tissue next.

Year over year growth was.

We're both very strong.

I think in previous quarters, I think previous quarter Q2, both were up.

Year over year growth was over 100%.

Maybe both have been slightly lower than the 100% year over year growth in Q3, but.

Sure.

Year to date reveal as though is still well over 100% year over year growth tissue next very close to 2% year over year. So.

Speaker 8: Yes, today's reveal is still well over 100% year-over-year growth. Tissue next, very close to 100% year-over-year. So, you know, good in the quarter, very strong yesterday. And so again, I think we're looking at closing the year-end strong about reveal in Tissue next.

Good in the quarter, a very strong year to date. So again I think we're looking at closing the year out strong on both sort of be on tissue.

Okay.

Speaker 1: Our next question comes from Pinyi Tsuida from Lyreng Partners. Let's go ahead.

Our next question comes from.

From Leerink partners. Please go ahead.

Speaker 8: You're hi, I'm early and I'll be thanks for taking the questions.

Yeah, Hi, merrily.

Thanks for taking the questions.

Yeah.

Speaker 12: maybe just on, you know, shield V2, can you just confirm that the bio bank samples that you have?

Maybe just on.

Shield read too.

Can you just confirm if the biobank samples that you have.

Speaker 12: untouched and unutilized in any of the trials so far that you can actually use them in the the pivotal trial for the shield v2 and get that submitted maybe just a clarification there a

Our untouched.

<unk> utilized in any of the trials. So far that you can actually use them in the pivotal trial for for the shield two and get that submitted.

Maybe just a clarification there first and then I'll have Bob.

Yes. So the short answer is yes more details we have enrolled about 45000.

Speaker 4: Yeah, so the short answer is yes. More details we have been drilled about 45,000. About 24,000 of them have been using the first study through the CRC's that we analyzed from, that first 24,000. And we have 20,000 plus more patient on touch. Blinded.

24000 of them have been using this first study through the CRC is that the annualized from that first 24000, and if you have 20000, plus more patient on touch blinded.

Crc's on touch blinded asset and almost the same and our buy.

Speaker 4: TRC's on touch blinded at fast-fed, you know, almost the same in our bi...

Bank.

Speaker 12: Got it. Okay. Thanks for that. And then just maybe one quick follow for you, I mean anything back from FDA, you pointed that the conversation is going well there, but I just wanted to see if there any updates.

Got it okay. Thanks for that and then.

Just maybe one quick follow up for you I'm not really I mean anything any feedback from SBA you pointed that.

The composition is going well there, but I just wanted to see if there are any updates on that front you pointed out but about 2024 approval still just wanted to get a sense of.

Speaker 12: On that front, you pointed out about 2024 approval still just wanted to get a sense of, you know, if you have any sort of guideposts in terms of, you know, earlier versus later or sort of first half versus first quarter, anything you can provide there would be super helpful.

If you have any sort of guidepost in terms of.

Earlier versus later or sort of first half versus first quarter anything you can provide there would be super helpful.

As I mentioned plan to your content to make.

Speaker 4: As I mentioned at point, we are continuing to make steady progress. Still, we are under review. We are not done with it. And it's very hard to predict the exact timing of it. But in the confidence level is very, very high. That would be in 2024, as we expected at the time that we submitted the PMA. So continues to be the thing. And the agency have been...

Andy progress still we are under review, we are not done with it and it's very hard to predict the exact timing of it but the confidence level is very very high that would be in 2024 as as we expected at the time that we submitted the PMA so continues to be.

Continues to be the same and the agency have been.

Speaker 4: then we will remove all the materials our

Very proud of the collaborative it vary.

Okay.

Speaker 4: Collegial kind of attitude toward our application, they understand the value of blood-based cancer screening, colorectal cancer screening. So if you're pleased with the reviews I kill so far.

Collegial kind of attitude toward our application they understand the value of blood based cancer screening colorectal cancer screening. So we are pleased with the review cycle, so far to see how it goes.

Speaker 1: Thank you. Our next question comes from Kyle Nixon from Canacord Community. Please go ahead.

Thank you. Our next question comes from Kyle Nixon from Canaccord Genuity. Please go ahead.

Perfect Hey, guys. Thanks for taking the questions.

Speaker 13: My question, I'm sorry Mike, given this G360 ASB trend benefiting from the multiple tailwinds with Medicare pricing, could you maybe just, you know, estimate I guess a telephoto if it's possible that G360 ASB could, you know, increase to some level by the end of 24, like if the average revenue percent approach, maybe like 30, about 100 by that point.

My question for you Mike.

Given this GBP 60, ASB trends benefiting from multiple wins with Medicare pricing.

Could you maybe just.

Estimate I guess tell us if.

It's possible that Jesus Asps could.

To some to some of them by the end of 'twenty four look at the average revenue per test approach, maybe like 3500 by that point and then also Mike just a question on cash flow what should we think about getting to breakeven by the end of this year and then kind of going forward.

Speaker 13: And then also, my, to the question, I'm like cash flow as we think about getting to be given by the end of this year and then kind of going forward. How diluted the cash flow generation is MRD and reveal like right now, you know, in other words, how much of an investment fee is there to advance that strategy and like given that return so far, that kind of like maintains revenue number.

How dilutive to cash flow generation is mardi and reveal like right now.

In other words, how much of an investment there to advance that strategy given that return so far that kind of a mid teens revenue number.

Thanks.

Speaker 14: That Karaluna, it's gone 360.

Yes.

The guidance <unk> Asps.

Speaker 14: Yeah, I mean, we've seen we've seen really good traction both on the on the medical side, you know, we have to wait for the finalization of

Yes, no I mean, we've seen we've seen really good traction both on the on the Medicare side, we have to wait for the Finalization of.

Speaker 14: clinical lab, B schedule yet, but, you know, if that comes through.

Clinical lab fee schedule, yet, but if that comes through will be.

Speaker 5: will be closing on 2900 at the start of next year. As I just mentioned on the call earlier, you know, there are potential other tailwinds, you know, we could see medical advantage come through, we could see that also help with private payer payments for gun and pre-sick PLBT.

Closing in on 2900.

At the start of.

Southern next year as I've, just mentioned on the call earlier.

Potential.

On the tailwind.

We could see Medicare advantage come through we can see that also helped with Pryor.

Payer pay.

Payments fall has gotten 360 <unk>. So I think we think we've seen good traction we set out.

Speaker 5: So I think we've seen the traction we set out on our investor day, or was it eight weeks ago that we wanted to get to a target of 3000. So I think at the moment, we're feeling very confident.

Best today was eight weeks ago, everyone. It to get to a target of 3000. So I think I think at the moment, we're feeling very confident we can get it we've got north of 3000.

Speaker 5: We can get north of 3000. Definitely in the five year timeline we set on the best state. But I think probably we're turning towards that a little bit earlier than we would have anticipated.

Five year timeline, we said on Investor day.

I think probably we're trending towards that a little bit earlier than we would.

What about <unk>.

And exactly what you're asking.

The latter will have to see how these headwinds rollout, but again, we're confident and then.

Speaker 8: on MRD. I think we've broken it out before. Probably the net investment on MRD takes into account the cost of processing the test this year, the research and development efforts that are going into it and the data development efforts, as well as the sales and marketing costs.

MRV.

I think we've broken it out before probably the next investment on the MLP takes into account the cost.

Of processing the test this year.

The research and development efforts that are going into it and the data development efforts as well as the sales and marketing costs.

Speaker 5: You know, probably a net investment of around $100 million this year.

Probably in that investment of around $100 million.

This year give or take.

Speaker 5: And we see that likely continuing into at least 2024. Of course, the key for us, and we're managing the volumes to try and stay managed by cash burn. And yeah, the key for us going forward is really to get additional reimbursement. And we've talked about CRC surveillance and then other indications. So that's what we're really focused on with MRB and at the same time managing the burn.

We see that likely continuing into 'twenty.

2020 for of course, the key for US and we are managing the volumes to try and stay manage the cash burn.

The key for us going forward is really to get <unk>.

Reimbursement, we've talked about CRC silence and then other indications. So that's what we're really focused on with that with MRP and at the same time managing the <unk>.

In the past.

Speaker 13: Okay, that was fantastic. My thanks so much for that. And then, primarily, we're on screen for you. The approval of FEMA is pretty likely. I think you mentioned like, mid-24 around there for SHIELD. What's the latest thinking there for you on the label? Are you ultimately a team? Like being a second line, third line test? Just wondering if you discussed that with the FDA at all or maybe that's included in your opinions in this PMA submission.

Okay that was fantastic. Thanks, so much for that and then I'm really went on screening for you.

The approval seems pretty likely I think you mentioned like mid 24 around there for shield, what's the latest thinking there for you on the label that you ultimately obtain what being a second line third line test I'm. Just wondering if you could discuss that with the FTA at all or maybe Thats included in the <unk>.

Your opinions and this PMA submission.

Speaker 4: So just to clarify, I think the mid-24 timeline that I mentioned was connected to the potential time that USPSC have reviewed cycle in terms of some of the early data research would start based on our understanding of the process.

And just to clarify I think.

May 24 timeline that I mentioned I was kind of exited to the potential time that.

USPS TF review cycle in terms of <unk>.

Early data research would start based on our understanding of the process.

Speaker 4: In terms of label, we haven't got to the label negotiation yet so far. There's been some conversation with agents see about this matter. And I think so far so good, but we'll see when we go to the official label negotiation phase.

In terms of label, we haven't got to the labor negotiation, yet so far there has been some conversation with agency about this matter on.

So far so good but we will see when we go to the artificial.

Tight labor negotiation phase what happens.

Speaker 1: Thank you. We will move on to the next question. Now Jack, may I hand from research? Please go ahead.

Thank you move onto the next question Jack.

From Trumpf research. Please go ahead.

Thank you good afternoon.

Speaker 15: For Helmi, I have a couple of questions on the G360 volumes. First is with breast cancer, the dynamic you called out. What's curious, do you think this sequentially continues to taper in 4Q or is that bolus normalized at this point? And second, you know, bond's obviously pretty strong. I was just curious with the dynamic backdrop, we're seeing, are you seeing any changes in market share versus tissue or other liquid players? Thank you. No. Worried, I see.

For me I had a couple of questions on the <unk> hundred 60 volumes first is with breast cancer. This dynamic you called out.

Was curious do you think the sequentially continues to taper in <unk> or is that bolus normalized at this point.

Second.

The bonds are obviously pretty strong I was just curious with that dynamic backdrop, we're seeing.

Are you seeing any changes in market share versus tissue or other liquid players. Thanks.

Yes.

Speaker 8: Yeah, no, as I said, there was this sort of warehousing effect that happened where you had to spend up demand for everyone that wanted to get on the drug. And so we had a huge jump up. And we believe we've completely worked through that bulless. And now we're just continuing on a very nice trajectory. And yeah, I want to highlight that we're still at extremely elevated levels of breast cancer testing than we were a year ago. I think year over, year over.

As I said, there was sort of warehousing effect that happened where you had this.

Pent up demand for everyone that wanted to get on the drug and so we had a huge jump up and we believe we've completely worked through that bullets now.

Now.

Continuing on a very nice trajectory in yes.

I want to highlight that we're still extremely elevated levels of breast cancer testing than we were a year ago I think year over year, we're over 100%.

Speaker 8: growth and so we're very excited in terms of where we are with breast cancer and

And so we're very excited in terms of where we are with breast cancer and I think now on kind of the right trajectory here now that we've worked our way through.

Speaker 8: kind of the right trajectory here now that we've worked our way through that bullets. Yeah, in terms of sort of competition.

That said bullets.

Yes in terms of sort of competition.

Speaker 8: I think we're seeing a little of the same dynamics, play out, have been flows of the usual suspects out there, but we continue to be the leader, undisputed leader, in terms of liquid biopsy, especially in therapy selection. So we're just chugging away, and obviously, as we said, we have all these catalysts coming up in terms of...

I think we're seeing a lot of the same dynamics play out of the inflows of the usual suspects out there, but we continue to be the leader undisputed leader in terms of liquid biopsy.

Especially in therapy selection.

Just chugging away and obviously as we said we have all these catalysts coming up in terms of.

Really working.

Speaker 8: Really much closer level with a lot of the important oncology practices around either through EMR or other sort of center-wide arrangements. So we're very excited about what this sort of next phase both for garden 360 testing and revealed.

Really much closer level with a lot of the <unk>.

Important oncology practices around either.

Our other.

Sort of a center wide arrangements and so we're very excited about what this sort of next phase.

Bodes for Garden, 360 testing and reveal test.

Speaker 15: Right. And one question for Mike, with the pricing improvement for G360 that you're seeing, um, was curious if there's any flag you're willing to put in the ground for cash burn in 2024. Just with the trajectory you're on with that improvement, what's the good landing spot for next year?

Great.

One question for Mike with the pricing improvement for <unk> hundred 60 that Youre seeing.

Was curious if theres any flag youre willing to put in the ground for cash burn in 2024.

Just with the trajectory we're on with that improvement.

What's a good landing spot for next year.

Speaker 14: You know, I mean, I think if you look at our investment day slide, you know, we said we said this year was a year of reduction of cash.

I mean, I think if you look at our Investor Day slides. We said we said this year was a year of reduction of.

Cash burn.

Speaker 14: Next year we'll be doing, you know, we've said over the next five years we expect the cash burns to come down each year. Although I want to sort of caveat that because it is a year of launch within screening, we're still making investments on NMRB, or, you know, we'll definitely see therapy selection flip to generating positive cash flow. So I think it'll be, you know, a little bit lower than this year.

Next year it will be too we've said over the next five years, we expect the cash burn to come down each year.

Although I wanted to sort of caveat that because it is a year of launch within screening we are still making investments on an MLP.

We'll definitely see therapy selection flip to generate positive cash flow. So I think it will be a little bit lower than this year.

Speaker 14: But not too much slower because again, we need to invest in the launch. But yeah, just to reiterate, you know, we'll end the year with a billion in cash.

But but not too much slower because again, we need to invest in the launch but.

But yes just to reiterate.

We will end the year with a $1 billion in cash and we still see that that's been out to get us through to cash flow breakeven in the five year timeline.

Speaker 5: And we still see that has been able to get us through to a cash low break even in the five year timeline. We pointed out a thing.

Once it out at the Investor day.

Thank you. Our next question comes from Dan Brennan from TD Colin. Please go ahead.

Speaker 1: Thank you. Our next question comes from Dan Brennan from PD Cohen. Please go ahead.

Speaker 9: Hey, thanks for thanks to the questions. I think that's on the quarter. Maybe the first one just on reveal. Could you just kind of walk us through the roadmap forward in terms of how we should think about filing for expanded coverage, both in CRC, and then also be interested here about what expectations should be for the upcoming data at Cent Antonio Breast and how that could play into your Medicare filing plans and breast.

Hey, Thanks for thanks for the questions Congrats on the quarter, maybe the first one just on reveal.

Could you just kind of walk us through the roadmap forward in terms of how we should think about filing for expanded coverage.

Both in CRC, and then also being able to hear about what expectations should be for the upcoming data at San Antonio breast and how that could play into your Medicare filing plans in breast.

Speaker 8: Yeah, so, you know, as we speak, we're putting, I think some of the cosmos data for...

Yes.

As we speak we're putting I think.

Some of the Cosmos data for.

Speaker 8: call and cancer, getting it ready for publication. So hopefully once that's published, that is something that would really make up the majority of our submission to multi-X for that expanded surveillance CRC indication. As we speak, we're seeing a lot of, I think, good.

Colon cancer.

Ready for publication and socially.

Once that's published that as something that would really make up the majority of our submission to mol Dx for the expanded surveillance.

CRC.

Indication.

As we speak we're we're seeing a lot of I think good breast cancer data.

Speaker 8: breast cancer data internally, we've also made a lot of good progress on one cancer as well. And so we're hopeful that we'll be able to have something out there certainly hopefully published sometime.

Internally.

We've also made a lot of good progress on lung cancer as well and so we're hopeful that.

We will be able to have something out there.

Certainly hopefully published sometime in 'twenty four.

Speaker 8: that submitted as well to MOL-DX. So we think we're later focused on breast, colon, and lung cancers. We have obviously multiple other cancers in the pipeline as well, but within those three indications, we'll get us.

Submitted as well too.

So we think.

We are laser focused on breast colon and lung cancers.

Obviously multiple other cancers in the pipeline as well, but within those three indications but get us.

Speaker 8: really a long ways of the way we need to be to have a reasonably reimbursed product for

Along ways of the way that we need to be.

Reasonably reimbursed products for reveal.

Speaker 9: And with the data at Centrentonium Breast, that'll be a piece of the larger filing package, Helmink, for Breast.

And with the data at San Antonio breast wood that will be a piece of the larger filing package for breath.

Yes, I mean, we continue to have.

Speaker 8: Yeah, I mean, we continue to have data, you know, we had data as small that was already compelling.

Data.

We had data at ESMO, there was a very compelling.

Speaker 8: I think we'll have additional data.

And Russ I think love additional data.

Speaker 8: but you know, we have some other studies as well, but may make up the...

And San Antonio.

<unk>.

We have some other studies as well.

Makeup.

Bulk of the submission.

Yeah, we are sort of multiple shots on goal.

Speaker 8: Yeah, we have sort of multiple shots on the go. It won't be relying.

Relating to just one study.

Speaker 1: Thank you. Our next question comes from Patrick Donnelly from City. Take a go ahead.

Thank you. Our next question comes from Patrick Donnelly from Citi. Please go ahead.

Speaker 15: Hey guys, thanks for taking questions. Help me maybe just on kind of the core business. It sounded like breast. Yeah, the backlog had some benefit from the pent up demand early in the year normalized a bit in 3Q. Can you talk about I guess the trends you're seeing there? It sounds like maybe the backlog you had, you worked through and now it's just kind of executing on the healthy backdrop, but it would be curious just a little more on the moving piece of the air and the right way to think about that going forward.

Hey, guys. Thanks for taking the questions.

Maybe just on kind of the core business it sounded like breast.

Backlog had some benefit from the pent up demand early in the year normalize a bit in <unk> can you just talk about I guess the trends youre seeing there it sounds like maybe the backlog have you worked through and now its just kind of executing on the healthy backdrop, but would be curious just a little more on the moving pieces there in the right way to think about that going forward.

Speaker 8: Yeah, I think now we're sort of a normalized race and now it's just a matter of getting additional patients tested. You know, one thing, we see a lot of room to grow, even for ESR1 and for breast cancer testing. We're seeing data out there that despite, you know, I think very large increase in volume of breast tests.

Yes, I think now we're sort of at normalized rates.

No. It's just a matter of getting additional patients tested.

We see a lot of room to grow.

Even for <unk> for breast cancer testing, we're seeing.

Data out there that.

Despite.

I think very large increase in volume of breath testing that a lot of patients.

Speaker 8: A lot of patients are still being tested by tissue or by other methods to try to assess CSR1.

Still to be tested by tissue or by other methods to to try to assess CSR one.

Speaker 8: It's very important, but physicians know that it's very unlikely to detect one mutation, since they're often emergent mutations or distance mutations, through an archival tissue bias.

It's very important that physicians know that.

It is very unlikely to text.

Yes, our one mutation since they are often emergencies mutations resistance mutations through an archival tissue biopsy and so there is.

Speaker 8: So there's obviously more work to do, but that is a, I think, opportunity for us to continue to increase volumes, I think, considerably. And obviously, in the other cancer types, you know, outside of lung and breast, I think there's still a lot more room to grow. So CGP, I think, is still not public mind.

Obviously more work to do but that is a I think opportunity for us to continue to increase volumes, though I think consider it at the end of it.

And the other cancer types outside of lung and breast.

Theres still lot more room to grow so.

<unk> I think it is still not top of mind.

Speaker 8: many patients and yeah we're continuing to see I think that there can be considerable

For many patients and we're continuing to see.

That.

There can be considerable growth for years to come.

Speaker 16: Okay, that's helpful. And then maybe just another quick one on reveal. It sounds like smart liquid biopsy upgrade is on track for the end of the year. If you just talk through, I guess the impact there, what we should be thinking as that rolls out.

Okay. That's helpful. And then maybe just another quick one on reveal.

It sounds like smart liquid biopsy upgrade is on track for the end of the year can you just talk through I guess the impact there what we should be thinking is that as that rolls out.

Speaker 8: Yeah, we're very excited to move to that platform, obviously.

Yes, we're very excited to move to that platform obviously is.

Speaker 8: You know, even better performance than where we are now from a sensitivity and specificity point of view.

Even better performance and where we are.

Now from a sensitivity and specificity point of view.

Speaker 8: But I think more so, the types of capabilities that as they will be able to provide in terms of, not just telling the sort of what in terms of, as the cancer they're not, but what's happening with the cancer, where is the cancer? And so while the transition initially may be somewhat invisible or very low impact, we think over time as we start layering in these new features, it'll be really exciting.

But I think more so the types of capabilities that.

It will be able to provide in terms of not just telling the sort of the what in terms of the cancer, there or not but.

Whats happening with the cancer, whereas the cancer and so while the transition initially maybe somewhat invisible or very low impact we think over time as we start layering in these new features that will be really exciting in terms of where the <unk> space those and they're really using this tool.

Speaker 8: where the MRD space goes. And you're really using this tool as a sort of blood-based equivalent of a CT scan. And it's going to be really exciting.

A sort of <unk>.

<unk> based equivalent of a <unk> scan.

It really exciting for us.

Apologies.

Speaker 1: Thank you. Next question comes from Derek De Bruyne from Thanks America. Take care.

Thank you next question comes from Derik de Bruin.

From Bank of America. Please go ahead.

Speaker 16: Hi, thanks for taking my question. Two questions first. Just on the going back to V2 on shield, can you explain why the A...

Hi, Thanks for taking my question too.

Two questions first just on the.

Going back to be too on shield.

Can you explain why the agencies.

Speaker 16: detection didn't go up, even though the sensitivity increased pretty significantly between V1 and V2. But just trying to get my head around that. And then second question to be any comments on volumes that you're thinking about for 2024, you're still expecting something in the 30% growth rate for next year. Thanks.

Detection didn't go up.

Though the sensitivity increased pretty significantly between <unk> and <unk>.

Trying to get my head around that and then second question would be any comments on volumes that youre thinking about for 2024, you still expecting something in the 30% growth rate for next year. Thanks.

Speaker 4: So, fortunately, to an advanced anti-nummer, yes, we did the same improvements on AA side and...

So for sure the China adverse adenoma, yes, we did see improvements on a site and.

Speaker 4: From that data, it's not very clear exactly how we should read into it. You know, it could have multiple reasons including the level of shedding of these advanced advanced? 51, but today it's in September that was done with cooling no.

From that data, it's not very clear exactly how we should read into it unites could have multiple resent, including the level of shedding of these advanced adenoma signals.

Speaker 4: are still lower than our level of detection. So, you know, we, even with improved detection limits that we have that we can effectively detect, like at least two X-lower levels of humor in blood.

Are still lower than our level of detection. So we even.

The event will improve.

Detection limits that we have that we can effectively detect.

At least <unk> lower levels of tumor and blood.

Speaker 4: That's not good enough to detect any material and amount of advanced heteronomus. That could be the reason or it could be like maybe just the biomarkers of advanced heteronomus for detection are different than the current epigenomic and genomic panel that we have that we are detecting CRC with. So still that's an area that we are looking into. We are doing research.

It's not good enough to detect any Matt Sheldon Mt.

And how much that could be a reason or it could be like maybe just the biomarkers of advanced adenomas for detection.

<unk> are different than the current epigenomics <unk> genomic panels that we have that we are detecting CRC with so that's an area that we are looking into we are doing research and as we generate more data as we generate more insights those data and insights.

Speaker 4: And as we generate more data, as we generate more insights, those data and insights.

Speaker 4: tell us more about what's maybe next for us to get into. At least some higher grade advanced set in almost over time.

Tell us more about what's may be next for us to get into at least some higher grade advanced adenomas overtime.

Okay.

Speaker 1: Our final question is call, come from Alex Novak from Craig Halen. Please go ahead.

Our final question from Alex Nowak from Craig Hallum. Please go ahead.

Speaker 17: Hi, good afternoon, everyone. This is Albert, who on for Alex. Can you please outline a bit more on the sales strategy after Shield FDA approval regarding initial ROC, sales team, primary call points, and just what to expect for 2024? 24.

Hi, Good afternoon, everyone. This is Albert who on for Alex.

Can you please outline a bit more on the sales strategy. After shields FDA approval regarding initial rough sales team primary call points and just what to expect for 2024.

Speaker 4: Yes, we outlined in our investor day, we are gonna expand actually our commercial team and we are gonna have about 100 people, 100, 150 people on the commercial side, all in that call point would be primary care physician. Subsimple for donation contains donated campaigns and uph ?????riØ debOr

Yes, as we outlined at our Investor day.

We are going to expand actually our commercial team and we are going to have about 100 people 100, 150 coupon the commercial side.

In the call point would be primary care physicians.

Speaker 4: And right now we have a small sales team in the field that they are promoting and doing some of the market development for shield even as a laptop, a look test, but we are going to go through that expansion. In near future.

And right now we have a small sales team in the field out there promoting at doing soft end market development for shield, even as a lab developed tests, but we are going to go through that expansion.

In near future.

Speaker 17: Great. And just as a follow up, also regarding SHIELD, though one of the back office activities or work, reimbursement personnel, customer service, et cetera, you need to bring, you need to have ready to bring the test online and get ready for day one of the FDA.

Great and just as a follow up.

So regarding shield, so while their back office activities or work reimbursement personnel customer servers et cetera, do we need to bring on.

Do you need to have ready to bring the test online.

And get ready for day, one of the FDA approval.

Yes.

Speaker 4: So we have some of those teams already in place because they shield their lutees in the market like you know

So we have some of those teams already in place because against share them with you in the market.

<unk>.

Speaker 4: Many, many thousands of samples have been processed from over a thousand plus accounts and...

Many many thousands of samples have been process from over 1000, plus headcounts and.

Speaker 4: Those teams are in place, it's just matter of scaling and some of the fixed costs is already there. It's just level based on the number of people that you're gonna hire in the field. We need to staff up some other personnel on the client services site, for instance. So all this is already in our commercial plan projections for 2024 and all this is included in the...

Those teams are in place, it's just a matter of scaling and some of that fixed cost is already there its just level based on.

The number of people that we are going to hiring the field, we need to staff up some other personnel on the client services site right. So all of this is already in our commercial plan projections for 2024 and all of this is included in the.

Speaker 4: Statement that we have that they contribute, contribution laws from screening next year would continue to be about that approximately 200 million dollar.

Statement that we had that contribute to the contribution loss from screening next year with content should be about approximately $200 million.

All of us are embedded there.

Speaker 1: Thank you. With that, we have reached the end of the conference call. Thank you all for attending. You may now disconnect your line. Thank you.

Thank you.

That we have.

The conference call. Thank you all for attending you may now disconnect your line.

Thank you with that we have.