Guardant Health Announces FDA Approval of Guardant360 CDx as Companion Diagnostic for Boehringer Ingelheim’s HERNEXEOS®

About this update from Guardant Health, Inc.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx as a companion diagnostic (CDx) for Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets), the first targeted therapy for adults with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) as an initial treatment option. The approval enables Guardant360 CDx, a liquid biopsy test that analyzes circulating tumor DNA (ctDNA) from a simple blood draw, to identify patients with HER2 (ERBB2) tyrosine kinase domain activating mutations who may be eligible for treatment with HERNEXEOS. HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. This indication was approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. More information and full prescribing information can be found at HERNEXEOS.com. “This approval highlights the growing impact of liquid biopsy across advanced cancer care and underscores the utility of Guardant360 CDx to ensuring more patients can be matched to the right therapy at the right time,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “Guardant360 CDx has been at the forefront of enabling comprehensive genomic profiling through a simple blood draw, helping clinicians identify actionable mutations in genes such as HER2 with speed and accuracy.” Guardant360 CDx was the first FDA-approved liquid biopsy that provides comprehensive genomic profiling across multiple tumor types and biomarkers. By detecting tumor-derived alterations in circulating cell-free DNA, the test helps clinicians match patients to appropriate targeted therapies and clinical trials. “Companion diagnostics are essential to personalized lung cancer care, guiding biomarker-driven treatment decisions,” added Vicky Brown, U.S. Therapeutic Area Head for Oncology and Emerging Areas, Boehringer Ingelheim. “Guardant360 CDx will help identify patients with HER2-mutant advanced non-small cell lung cancer and connect eligible patients to the appropriate targeted ...

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