Guardant Health, Inc. (GH) announced that the U.S. FDA has approved Guardant360 CDx, a liquid biopsy test, as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS (zongertinib tablets), the first targeted therapy for adults with HER2-mutant advanced non-small cell lung cancer (NSCLC).
HERNEXEOS is indicated for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.
The approval was granted under the FDA's accelerated approval pathway based on objective response rate and duration of response, with continued approval contingent on confirmatory clinical data.
Guardant360 CDx is a blood-based liquid biopsy test that analyzes circulating tumor DNA (ctDNA) from a simple blood draw to identify patients with HER2 tyrosine kinase domain activating mutations who may be eligible for treatment with HERNEXEOS.
The test was the first FDA-approved liquid biopsy to provide comprehensive genomic profiling across multiple tumor types and biomarkers, helping clinicians match patients to targeted therapies and clinical trials through detection of tumor-derived alternations in cell-free DNA.
Guardant Health said the approval underscores the growing role of liquid biopsy in advanced cancer care. Helmy Eltoukhy, the company's chairman and co-CEO, noted that Guardant360 CDx has been central to enabling comprehensive genomic profiling through a simple blood draw, helping clinicians identify actionable mutations in genes such as HER2 with speed and accuracy.
Boehringer Ingelheim highlighted the importance of companion diagnostics in guiding biomarker-driven treatment decisions. Vicky Brown, U.S. Therapeutic Area Head for Oncology and Emerging Areas said the test will help identify patients with HER2-mutant advanced NSCLC and connect eligible individuals to the appropriate targeted therapy when timely decisions are critical.
GH has traded between $40.35 and $134.28 over the past year. The stock is currently trading at $130.01, down 0.53%.
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