Thermo Fisher signs agreement with Blueprint Medicines

Thermo Fisher Scientific has expanded the development of its Oncomine Dx Target Test by entering into an agreement with Blueprint Medicines Corporation to develop and commercialize the Oncomine Dx Target Test as a companion diagnostic (CDx) for BLU-667 to identify RET fusions in people with non-small cell lung cancer (NSCLC).

This step has been taken as part of its ongoing commitment to increase the utility of next-generation sequencing (NGS) in the clinic.

BLU-667 is a potent and selective inhibitor of the kinase RET, including RET fusions and mutations, currently being evaluated by Blueprint Medicines in a Phase 1 clinical trial for the treatment of patients with RET-driven NSCLC, thyroid cancer and other advanced solid tumors.

Once validation is complete, Thermo Fisher will submit a supplemental premarket approval application to the U.S. Food and Drug Administration (FDA) to expand the clinical claims for its Oncomine Dx Target Test.

Under the terms of the agreement, Thermo Fisher will also retain the rights to commercialize the test globally and will lead all necessary filings to seek clearance from regional regulatory agencies for the test.