Thermo Fisher Scientific Gains FDA Approval for Oncomine Dx Target Test in Certain Cancers

Thermo Fisher Scientific has received FDA approval for its Oncomine Dx Target Test, as a companion diagnostic to aid in selection of patients who may be eligible for treatment with Eli Lilly’s cancer drug Retevmo (selpercatinib).

The next-generation sequencing (NGS) test is specifically for patients with RET-fusion positive locally advanced or metastatic nonsmall-cell lung cancer (NSCLC), RET-fusion positive advanced or metastatic thyroid cancer and RET-mutation positive advanced or metastatic medullary thyroid cancer.

Retevmo is a RET kinase inhibitor — in a class of drugs used to treat cancer in individuals with tumors that have RET gene alterations.

The FDA approval marks the test’s first indication as a companion diagnostic for a therapy targeting RET-positive thyroid cancer and a second indication associated with RET-positive NSCLC.