Sept. 28, 2022—The FDA has approved Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to aid in selecting patients with RET-fusion positive locally advanced or metastatic non-small cell lung cancer, RET-fusion positive advanced or metastatic thyroid cancer, and RET-mutation positive advanced or metastatic medullary thyroid cancer who may be eligible for treatment with Lilly’s Retevmo (selpercatinib).
Retevmo is a selective RET (rearranged during transfection) kinase inhibitor and was the first therapy approved for patients with advanced RET-driven lung and thyroid cancers. The Oncomine Dx Target test is a next-generation sequencing–based test that can detect multiple alterations at once from a small sample size. It is also approved in Japan as a companion diagnostic for Retevmo in the same indications.
This is the Oncomine Dx Target test’s first approval as a CDx for a therapy targeting RET-positive thyroid cancer, Thermo Fisher says, and the second approval associated with RET-positive NSCLC.