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NEW YORK – Thermo Fisher Scientific said this week that the US Food and Drug Administration has granted Breakthrough Device Designation for its Oncomine Precision Assay to identify low-grade glioma patients with isocitrate dehydrogenase 1 and 2 mutations and who may be eligible for treatment with vorasidenib (AG-881). The assay is designed to run on the Ion Torrent Genexus sequencing platform. Thermo Fisher is codeveloping a companion diagnostic for vorasidenib with Agios Pharmaceuticals.

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