Thermo Fisher Scientific Gets FDA Premarket Approval for Companion Diagnostic

Thermo Fisher Scientific has received premarket approval from the FDA for its Oncomine Dx Target Test as a companion diagnostic for AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki).

The test looks for biomarkers to identify patients whose tumors have a HER2 (ERBB2) activating mutations in nonsmall-cell lung cancer (NSCLC) who may be candidates for Enhertu therapy. The FDA has also granted Enhertu accelerated approval for the indication.

The test uses next-generation sequencing technology to simultaneously detect 23 genes associated with NSCLC, while traditional companion diagnostic technologies can only analyze one target gene at a time.

Oncomine Dx received its first FDA approval as a companion diagnostic in 2017. It is now approved for seven targeted therapies for NSCLC and one for bile duct cancer.