CARLSBAD, Calif., May 18, 2017 /PRNewswire/ -- Thermo Fisher Scientific announced today that it has entered into an agreement with Agios Pharmaceuticals, Inc. to develop and commercialize a next-generation sequencing (NGS) oncology companion diagnostic (CDx) for ivosidenib (AG-120) to identify isocitrate dehydrogenase 1 (IDH1) mutations in cholangiocarcinoma patients. Ivosidenib is an IDH1 inhibitor currently in a Phase 3 trial (ClarIDHy, NCT02989857) for the treatment of patients with advanced IDH1m positive cholangiocarcinoma.
Cholangiocarcinoma is a rare form of cancer that affects the human bile duct system with a high unmet medical need. Annual incidences of the disease are estimated to be from 1-2 per 100,000, but rates globally have been on the rise over the last several decades.1
Thermo Fisher is currently Agios' technology partner in the Phase 3 ClarIDHy trial, providing NGS for all tumor samples as inclusion criteria for enrollment. Upon validation of the CDx, Thermo Fisher will submit a supplemental premarket approval application to expand clinical claims for its multi-therapy NGS test that is currently awaiting approval by the U.S. Food and Drug Administration.
Under the terms of the agreement, Thermo Fisher will retain the rights to commercialize the test globally and will lead all necessary filings to seek clearance from regional regulatory agencies. Use of an approved multi-gene CDx to simultaneously screen patients for targeted therapies is a shift away from the conventional testing method of running several, single-biomarker analyses in sequence to identify tumor profiles. Thermo Fisher aims to change the paradigm from one test for one drug, to one test for multiple therapies.
"This agreement with Agios underscores our continued commitment to help bring precision oncology to the forefront through the use of next generation sequencing technology," said Joydeep Goswami, president of Clinical Next-Generation Sequencing and Oncology at Thermo Fisher Scientific. "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."
Thermo Fisher's NGS-based test is designed to simultaneously screen patient tumor samples for multiple gene variants, minimizing the need to perform numerous sequential analyses in an effort to generate a relevant tumor profile. The CDx in development will use Thermo Fisher's Ion PGM™ Dx System, Ion AmpliSeq™ technology and relevant content from its Oncomine™ portfolio of gene targets.
1 Patel T (2002). "Worldwide trends in mortality from biliary tract malignancies." BMC Cancer.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $18 billion and more than 55,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.
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SOURCE Thermo Fisher Scientific Inc.