PALO ALTO, Calif., June 11, 2026
Guardant Health announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx as a companion diagnostic for Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets), the first targeted therapy approved for adults with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) as an initial treatment option. The approval enables clinicians to use Guardant360 CDx, a blood-based liquid biopsy test, to identify eligible patients carrying HER2 tyrosine kinase domain activating mutations and match them with the newly approved targeted therapy. The milestone further strengthens the role of precision oncology and liquid biopsy technology in accelerating personalized cancer treatment decisions.
FDA Approval Expands Access to Precision Oncology Through Liquid Biopsy
Guardant360 CDx analyzes circulating tumor DNA (ctDNA) from a simple blood draw, providing a minimally invasive alternative to traditional tissue biopsy. The FDA approval allows the test to identify patients with unresectable or metastatic non-squamous NSCLC whose tumors harbor HER2 (ERBB2) tyrosine kinase domain activating mutations and may benefit from treatment with HERNEXEOS. Because advanced lung cancer patients often face challenges obtaining adequate tissue samples, liquid biopsy testing offers a faster and more accessible approach to genomic profiling, enabling timely treatment selection and reducing delays in initiating targeted therapy.
Companion Diagnostic Supports First HER2-Targeted Therapy in Advanced NSCLC
HERNEXEOS received FDA approval under the accelerated approval pathway based on objective response rate and duration of response data. The therapy represents the first targeted treatment specifically approved for HER2-mutant advanced non-small cell lung cancer as an initial treatment option. HER2-mutant NSCLC is considered an aggressive subtype of lung cancer associated with poor clinical outcomes and limited treatment options. The availability of an FDA-authorized companion diagnostic is expected to improve patient identification and support broader adoption of biomarker-driven treatment strategies. Guardant Health noted that comprehensive genomic profiling through liquid biopsy can help clinicians rapidly detect actionable alterations and guide precision medicine decisions across advanced cancer care.
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Growing Clinical Utility Strengthens Guardant360 Platform Leadership
The latest approval marks the 27th companion diagnostic indication globally for Guardant360 CDx, reflecting the platform’s expanding role across multiple tumor types and targeted therapies. Guardant360 CDx was the first FDA-approved liquid biopsy to provide comprehensive genomic profiling for solid tumors and currently supports treatment decisions across lung cancer, breast cancer, and colorectal cancer indications. The platform is widely covered by Medicare and commercial insurers, representing more than 300 million covered lives. Guardant Health believes the approval further validates the growing importance of liquid biopsy technology in oncology, helping physicians identify actionable genomic mutations with speed and accuracy while improving access to personalized treatment options for cancer patients worldwide..
Source: Guardant Health, press release
