FDA approves Guardant360 CDx for HERNEXEOS
Analysis based on 8 articles · First reported Jun 11, 2026 · Last updated Jun 11, 2026
The FDA approval of Guardant360 CDx as a companion diagnostic for HERNEXEOS is positive for both Guardant Health and Boehringer Ingelheim. It expands Guardant Health's market reach and validates its liquid biopsy technology, potentially boosting its stock price. For Boehringer Ingelheim, it enables the launch of a new targeted therapy for HER2-mutant NSCLC, opening a new revenue stream and addressing an unmet medical need.
The United States — Food and Drug Administration (FDA) has approved Guardant360 CDx, a liquid biopsy test developed by Guardant Health, as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS (zongertinib tablets). HERNEXEOS is the first targeted therapy for adults with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) as an initial treatment option. This approval allows Guardant360 CDx to identify patients with HER2 tyrosine kinase domain activating mutations who may be eligible for HERNEXEOS treatment. The indication was approved under accelerated approval based on objective response rate and duration of response, with continued approval contingent upon verification in a confirmatory trial. This marks the 27th companion diagnostic indication for Guardant360 CDx globally, highlighting the increasing role of liquid biopsy in personalized cancer care.
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