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Thermo Fisher, Agios Pharmaceuticals Strike CDx Partnership

NEW YORK (GenomeWeb) – Thermo Fisher Scientific announced today that it has signed an agreement to develop and commercialize a next-generation sequencing-based companion diagnostic for Agios Pharmaceuticals' investigational cancer drug ivosidenib.

Ivosidenib is an inhibitor of isocitrate dehydrogenase 1 (IDH1), which is mutated in various cancers. It is currently in Phase III testing in patients with cholangiocarcinoma — a rare cancer of the bile duct system — who harbor IDH1 mutations.

Thermo Fisher is currently Agios' partner on a Phase III trial of ivosidenib, providing NGS services for all tumor samples as inclusion criteria to study enrollment. Under the terms of their deal, the companies will work together to validate a companion diagnostic based on Thermo Fisher's Ion PGM Dx system, Ion AmpliSeq technology, and Oncomine portfolio to identify IDH1 mutations.

The test is already under US Food and Drug Administration review for use with other therapeutics, and Thermo Fisher will submit a supplemental premarket approval application to expand its clinical claims. Thermo Fisher will retain the worldwide rights to commercialize the test and be responsible for all filings with regional regulatory agencies.

Additional terms were not disclosed.

"By supplementing our existing test, instead of developing a new one, we are helping our pharmaceutical partners expedite their drug development programs so that patients can potentially benefit more quickly from targeted therapies," Joydeep Goswami, president of clinical NGS and oncology at Thermo Fisher, said in a statement.

Agios has also previously forged companion diagnostic partnerships for its drug candidates with Abbott and Foundation Medicine.

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