Guardant Health, Inc. (NASDAQ:GH) secured U.S. Food and Drug Administration approval for its Guardant360 CDx liquid biopsy test as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS, the first targeted therapy approved for HER2-mutant advanced non-small cell lung cancer as an initial treatment option.

Key Highlights

  • FDA approval secured: The FDA approved Guardant360 CDx as a companion diagnostic for HERNEXEOS (zongertinib tablets), the first targeted therapy for adults with HER2-mutant advanced non-small cell lung cancer as a first-line option.
  • Blood-based identification: Guardant360 CDx uses a liquid biopsy to analyze circulating tumor DNA from a simple blood draw, identifying patients with HER2 tyrosine kinase domain activating mutations eligible for treatment with HERNEXEOS.
  • 27th CDx indication: The approval marks the 27th companion diagnostic indication for the Guardant360 CDx platform across multiple tumor types globally, expanding coverage to over 300 million lives across Medicare and commercial payers.
  • Accelerated approval pathway: HERNEXEOS received approval under the FDA's accelerated approval pathway based on objective response rate and duration of response, with continued approval contingent on confirmatory clinical trial data.

Guardant Health, Inc. (NASDAQ:GH) announced Thursday that the FDA has approved Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS, also known as zongertinib tablets, marking the entry of a targeted blood-based diagnostic into one of oncology's most underserved patient segments.

HERNEXEOS is indicated for adult patients with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors carry HER2, or ERBB2, tyrosine kinase domain activating mutations, as identified 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. Continued approval remains contingent upon verification of clinical benefit in a confirmatory trial.

The approval enables Guardant360 CDx, which was the first FDA-approved liquid biopsy to provide comprehensive genomic profiling across multiple tumor types and biomarkers, to identify patients who may be eligible for treatment with HERNEXEOS. The test detects HER2 tyrosine kinase domain activating mutations from circulating tumor DNA extracted from a standard blood draw, offering a faster and less invasive alternative to tissue biopsy, which can be technically difficult in patients with advanced disease.

HER2-mutant non-small cell lung cancer is considered an aggressive subtype associated with poor prognosis. NSCLC is the most common form of lung cancer, with a subset of patients carrying HER2 mutations that may be targeted with precision therapies. Prior to the approval of HERNEXEOS, no targeted first-line therapy had been approved for this specific mutation.

The Guardant360 CDx platform now carries 27 companion diagnostic indications across multiple tumor types globally, including approvals for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer. The platform has broad coverage across Medicare and commercial payers, reaching more than 300 million covered lives.

Guardant Health shares rose approximately 1.6% in premarket trading on Thursday following the announcement, before the broader session opened.