Thermo Fisher Scientific bags USFDA nod for NGS-based CDx Test for lung, thyroid cancers
The Oncomine Dx Target test is a next-generation sequencing (NGS)-based test that can detect multiple alterations at once from a small sample size, helping to quickly match patients with the appropriate targeted therapy.;
Carlsbad, Calif.: The U.S. Food and Drug Administration (USFDA) has granted approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to aid in selection of patients with RET-fusion positive locally advanced or metastatic non-small cell lung cancer (NSCLC), RET-fusion positive advanced or metastatic thyroid cancer and RET-mutation positive advanced or metastatic medullary thyroid cancer (MTC) who may be eligible for treatment with Lilly's Retevmo (selpercatinib). This marks the Oncomine Dx Target Test's first approval as a CDx for a therapy targeting RET-positive thyroid cancer and second approval associated with RET-positive NSCLC.
Initially approved in 2020, Retevmo is a selective RET kinase inhibitor and was the first therapy approved for patients with advanced RET-driven lung and thyroid cancers. RET (rearranged during transfection) alterations are found in approximately 2% of patients with NSCLC, which is the leading cause of adult cancer death in the United States, 60% of patients with MTC and 20% in other thyroid cancers.
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