Precision oncology company Guardant Health Inc (Nasdaq:GH) announced on Thursday that the US Food and Drug Administration (FDA) has approved Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim's HERNEXEOS (zongertinib tablets), a targeted therapy for adults with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) as an initial treatment option.

This approval enables the liquid biopsy test to identify patients eligible for treatment by detecting HER2 (ERBB2) tyrosine kinase domain activating mutations from circulating tumour DNA in a blood sample.

HERNEXEOS is indicated for adult patients with unresectable or metastatic non-squamous NSCLC with HER2 mutations as detected by an FDA-authorised test, under accelerated approval based on response metrics.

Guardant360 CDx, the first FDA-approved liquid biopsy for comprehensive genomic profiling across multiple tumour types, supports treatment matching and clinical trial identification. This approval marks the 27th companion diagnostic indication for the platform globally.