NEW YORK – Guardant Health and Thermo Fisher Scientific said on Friday that the US Food and Drug Administration has granted premarket approvals for their respective next-generation sequencing assays as companion diagnostics to Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate jointly developed and commercialized by Daiichi Sankyo and AstraZeneca, in non-small cell lung cancer.
The therapy, which was also approved by the FDA this week, is the first HER2-directed treatment to become available for lung cancer in the US. It had previously been approved for various applications in breast cancer.
Thermo Fisher's assay, Oncomine Dx Target, is a distributed kit designed to detect alterations in 23 genes associated with NSCLC.
Guardant's Guardant360 CDx is a blood-based liquid biopsy assay, performed by the company in its own lab, covering genomic alterations in circulating tumor DNA across 55 genes.
With their new CDx approval for Enhertu, the tests are now authorized for use in identifying lung cancer patients whose tumors have HER2 (ERBB2) activating mutations that make them candidates for treatment. These patients are estimated to represent up to 4 percent of the NSCLC population.