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Thermo Fisher Scientific, Blueprint Medicines Ink Companion Diagnostic Development Deal

NEW YORK (GenomeWeb) – Thermo Fisher Scientific said today that it has partnered with Blueprint Medicines to develop and commercialize its Oncomine Dx Target Test as a companion diagnostic for Blueprint's BLU-667 to identify RET fusions in non-small cell lung cancer patients.

Blueprint is currently evaluating BLU-667, a RET kinase inhibitor, in a phase 1 clinical trial to treat patients with RET-driven NSCLC, thyroid cancer, and other advanced solid tumors, and the CDx is supposed to help drive enrollment for the trial.

Following validation, Thermo Fisher plans to submit a supplemental premarket approval application to the US Food and Drug Administration to expand the clinical claims for the Oncomine Dx Target Test.

In June, the Oncomine Dx Target Test received FDA approval as a companion diagnostic for three NSCLC treatments, from AstraZeneca, Pfizer, and Novartis. At the time, Thermo Fisher said it was looking to expand the indications for the test as part of a strategic plan to develop one test for multiple therapies.

The test also recently received a positive coverage decision from Regence Blue Cross Blue Shield.

Under the new agreement, Thermo Fisher retains global rights to commercialize the test, which uses next-generation sequencing and runs on the company's PGM Dx system. The firm also plans to seek clearance from other regulatory authorities.

In May, Thermo struck a similar CDx development collaboration with Agios Pharmaceuticals to detect IDH1 mutations in cholangiocarcinoma.