FDA approves Guardant360 CDx as companion diagnostic for Boehringer’s HERNEXEOS in HER2-mutant NSCLC

Guardant Health

Guardant Health

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  • Guardant Health won FDA clearance for Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim’s HERNEXEOS (zongertinib) in HER2-mutant advanced NSCLC.
  • The blood test can identify HER2 (ERBB2) tyrosine kinase domain activating mutations to select eligible patients for the targeted therapy.
  • The label for HERNEXEOS was cleared under accelerated approval, with continued approval contingent on confirmatory trial results.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Guardant Health Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 202606110805BIZWIRE_USPR_____20260610_BW919127) on June 11, 2026, and is solely responsible for the information contained therein.

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