The U.S. FDA approved Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS (zongertinib), enabling use with the first targeted therapy for adults with HER2-mutant advanced non-small cell lung cancer. The decision is a meaningful regulatory and commercial catalyst for Guardant Health, strengthening the test's clinical utility and potential adoption. The news is positive for the company and its diagnostics franchise, though the broader market impact is limited.
The U.S. FDA approved Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS (zongertinib), enabling use with the first targeted therapy for adults with HER2-mutant advanced non-small cell lung cancer. The decision is a meaningful regulatory and commercial catalyst for Guardant Health, strengthening the test's clinical utility and potential adoption. The news is positive for the company and its diagnostics franchise, though the broader market impact is limited.
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