Thermo Fisher Scientific said today it will develop and commercialize its Oncomine Dx Target Test as a companion diagnostic for Blueprint Medicines’ Phase I BLU-667, with the goal of identifying RET fusions in patients with non-small cell lung cancer (NSCLC).
Under the collaboration, whose value was not disclosed, Thermo Fisher will also retain rights to commercialize the test globally and will lead all required filings to seek clearance from regional regulatory agencies for the test.
Thermo Fisher said the CDx will complement efforts to drive enrollment to a Phase I clinical trial by Blueprint Medicines. The company is now recruiting patients for the study, designed to assess BLU-667 in patients with RET-driven NSCLC, thyroid cancer and other advanced solid tumors (NCT03037385).
Once validation is complete, Thermo Fisher said, it will submit a supplemental premarket approval application to the FDA to expand the clinical claims for its Oncomine Dx Target Test.
Expansion of the CDx is part of a strategic plan by Thermo Fisher to develop one multi-gene test capable of screening patients for multiple therapies simultaneously—a shift from the conventional method of running several, single-biomarker analyses in sequence to identify tumor profiles.
Thermo Fisher’s collaboration with Blueprint Medicines is its second CDx development program with a drug developer. In May, Thermo Fisher agreed to develop and commercialize a next-generation sequencing (NGS) oncology companion diagnostic for Agios Pharmaceuticals’ Phase III cancer candidate ivosidenib (AG-120). The CDx will be designed to identify isocitrate dehydrogenase 1 (IDH1) mutations in patients with cholangiocarcinoma, a rare form of cancer that affects the human bile duct system.
Oncomine Dx Target Test received FDA approval in June, followed earlier this month by its first positive coverage decision by Regence Blue Cross Blue Shield.