Thermo Fisher and Agios to collaborate on Companion Diagnostic for Low-grade Glioma

Thermo Fisher Scientific and Agios Pharmaceuticals are to extend their collaboration with the co-development of a second companion diagnostic for oncology. The CDx will be used globally to identify low-grade glioma patients with isocitrate dehydrogenase 1 and 2 mutations who may be eligible for vorasidenib (AG-881), an investigational, oral, brain-penetrant inhibitor of IDH1 and IDH2 mutations that is being developed by Agios and is currently in the Phase 3 INDIGO study.

The two companies will work together to authenticate the biomarkers for a test to identify variant-positive patients. The test will be based on Thermo Fisher’s Oncomine Precision Assay, which runs on the new Ion Torrent Genexus System. This Assay is a next-generation sequencing assay for the detection of key biomarkers from formalin-fixed paraffin-embedded tissue or liquid biopsy specimen. Thermo Fisher Scientific will retain the global commercialisation rights and will take the lead on filing for the relevant regulatory approvals.

Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific, said: “The speed of the Genexus System in combination with the Oncomine Precision Assay has the potential to change the pace in which those diagnosed with LGG can be stratified and directed to a potentially more effective treatment in the future. We are committed to collaborating with leading pharmaceutical partners to make precision medicine accessible to more patients everywhere.”