The FDA approved Guardant Health's Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS (zongertinib), the first targeted therapy for HER2-mutant advanced NSCLC as an initial treatment option.
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Guardant Health wins FDA nod for HER2 lung cancer test as 27th CDx
The FDA approved Guardant Health's liquid biopsy as a companion diagnostic for Boehringer Ingelheim's first-line HER2-mutant lung cancer therapy.
"This approval highlights the growing impact of liquid biopsy across advanced cancer care," Helmy Eltoukhy, chairman and co-CEO of Guardant Health, said.
The Guardant360 CDx test detects circulating tumor DNA from a simple blood draw to identify patients with HER2 (ERBB2) tyrosine kinase domain activating mutations eligible for HERNEXEOS (zongertinib tablets). The approval marks the 27th companion diagnostic indication for Guardant360 CDx globally, with coverage from Medicare and commercial payers representing more than 300 million lives.
Blood-based testing offers a faster, less invasive alternative to tissue biopsy for patients with advanced non-small cell lung cancer, where tissue sampling can be difficult. HERNEXEOS received accelerated approval based on objective response rate and duration of response; continued authorization depends on verification of clinical benefit in a confirmatory trial.
NSCLC is the most common type of lung cancer, and a subset of patients harbor HER2 mutations associated with poor prognosis. Guardant360 CDx was the first FDA-approved liquid biopsy for comprehensive genomic profiling across solid tumors and now carries approved CDx indications in non-small cell lung cancer, breast cancer, and colorectal cancer.
"Companion diagnostics are essential to personalized lung cancer care, guiding biomarker-driven treatment decisions," Vicky Brown, U.S. Therapeutic Area Head for Oncology and Emerging Areas at Boehringer Ingelheim, said. "Guardant360 CDx will help identify patients with HER2-mutant advanced non-small cell lung cancer and connect eligible patients to the appropriate targeted therapy when timely treatment decisions matter most."
The expanded label strengthens Guardant Health's position in precision oncology diagnostics. Investors will watch for adoption trends in the coming quarters as physicians incorporate blood-based HER2 testing into first-line NSCLC treatment decisions.
This article is for informational purposes only and does not constitute investment advice.
[1] Guardant Health Announces FDA Approval of Guardant360 CDx as Companion Diagnostic for Boehringer Ingelheim's HERNEXEOS®[2] Guardant Health Announces FDA Approval of Guardant360 CDx as Companion Diagnostic for Boehringer Ingelheim’s HERNEXEOS - Business Wire[3] Guardant Health wins FDA approval for HER2 lung cancer test By Investing.com - Investing.com Canada[4] FDA Flashback: Breast Cancer Decisions and News From May 2026 - OncLive
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