Guardant Health Secures FDA Approval for Guardant360 CDx as Companion Diagnostic for Boehringer Ingelheim’s HERNEXEOS®
Guardant Health, Inc., 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 therapy when timely treatment decisions matter most.”
NSCLC is the most common type of lung cancer, and a subset of patients harbor HER2 mutations that may be targetable with precision therapies. HER2-mutant NSCLC is an aggressive type of lung cancer that has been associated with a poor prognosis. Blood-based testing offers a faster, less invasive alternative to tissue biopsy, which can be challenging in advanced disease.
This latest FDA approval for Guardant360 CDx marks the 27th CDx indication across multiple tumor types globally, building on the platform’s increasing clinical utility and broad coverage by Medicare and commercial payers, representing more than 300 million covered lives.
About Guardant360® CDx
Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling. It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer.
About Guardant Health
Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer.
