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Thermo Fisher, Agios to develop diagnostic for ivosidenib in cholangiocarcinoma
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Thermo Fisher Scientific and Agios Pharmaceuticals entered into a collaboration agreement to develop and commercialize a next-generation sequencing oncology companion diagnostic for ivosidenib to identify IDH1 mutations in patients with cholangiocarcinoma.
Ivosidenib (AG-120, Agios Pharmaceuticals), an IDH1 inhibitor, is being evaluated in the phase 3 ClarIDHy trial for treatment of patients with advanced IDH1–positive cholangiocarcinoma, a rare form of cancer that affects the bile duct system.
The companion diagnostic — which includes Thermo Fisher’s Ion PGM Dx System, Ion AmpliSeq technology and Oncomine portfolio of gene targets — is designed to simultaneously screen patient tumor samples for multiple gene variants.
The diagnostic test will provide next-generation sequencing for all tumor samples as inclusion criterial for enrollment in the ClarIDHy trial.
“This agreement with Agios underscores our continued commitment to help bring precision oncology to the forefront through the use of next-generation sequencing technology,” Joydeep Goswami, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific, said in a company-issued press release. “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.”
Upon validation, Thermo Fisher will submit a supplemental premarket approval application to the FDA to expand clinical claims for its multitherapy next-generation sequencing test, which is awaiting approval.