Guardant Health Announces FDA Approval of Guardant360 CDx as Companion Diagnostic for Boehringer Ingelheim’s HERNEXEOS®
The FDA approved Guardant Health’s Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim’s HERNEXEOS, the first targeted therapy for HER2-mutant advanced non-small cell lung cancer. This approval allows the liquid biopsy test to identify patients with specific HER2 mutations eligible for HERNEXEOS treatment, leveraging a simple blood draw instead of invasive tissue biopsy.
Key figures
- Drug Name
- HERNEXEOS (zongertinib)
- Covered lives
- 300 million
- Cdx indication count
- 27
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