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Thermo Fisher Scientific, Agios Pharmaceuticals to Codevelop Glioma Companion Diagnostic

NEW YORK – Thermo Fisher Scientific said on Tuesday that it has expanded its strategic partnership with Agios Pharmaceuticals to codevelop a companion diagnostic test to identify low-grade glioma patients with IDH1 and IDH2 mutations who may be eligible for Agios' investigational inhibitor vorasidenib.

Under the agreement, the partners will develop a companion diagnostic for vorasidenib, currently under evaluation in the Phase 3 INDIGO study, using Thermo Fisher's Oncomine Precision Assay, a next-generation sequencing panel on the Genexsus system that covers more than 50 genomic targets. Thermo will retain the rights to commercialize the test globally and will take the lead in seeking clearance from appropriate regulatory agencies.

The new deal follows a similar 2017 agreement between the companies to develop and commercialize a companion diagnostic to identify patients with IDH1-mutant cholangiocarcinoma who may be eligible for ivosidenib (marketed by Agios as Tibsovo). Data from the resulting Phase 3 ClarIDHy clinical study were presented at the last year's European Society for Medical Oncology Congress.

Financial terms of the expanded agreement were not disclosed.