Thermo Fisher Scientific to Co-develop Global Companion Diagnostic for Low-grade Glioma

Thermo Fisher Scientific has expanded its strategic partnership with Agios Pharmaceuticals by adding the co-development of a second companion diagnostic (CDx) for oncology to their existing agreement. The CDx will leverage the Oncomine Precision Assay, which runs on the new Ion Torrent Genexus System, and will be used globally to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be eligible for vorasidenib (AG-881). Vorasidenib is an investigational, oral, brain-penetrant inhibitor of IDH1 and IDH2 mutations that is being developed by Agios and is currently under evaluation in the Phase 3 INDIGO study.

Gliomas represent a broad range of primary brain tumors, ranging from highly aggressive glioblastomas to slow-growing LGG. About 11,000 new LGG patients are diagnosed in the U.S. and Europe each year, and about 80 percent have an IDH1 gene mutation. Patient symptoms range from seizures and neurologic deficits to sensory impairment and changes in behavior, with a five-year survival rate of 33 percent.

"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," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "We are committed to collaborating with leading pharmaceutical partners to make precision medicine accessible to more patients everywhere."

Under the terms of the agreement, the companies will collaboratively validate the biomarkers for a test that will be based on Thermo Fisher's Oncomine Precision Assay and used to identify variant-positive patients. Thermo Fisher will retain the rights to commercialize the test globally and will lead filings to seek clearance from the appropriate regulatory agencies.

The new agreement follows a 2017 partnership between the companies to develop and commercialize a CDx to identify patients with IDH1 mutant cholangiocarcinoma who may be eligible for TIBSOVO® (ivosidenib or AG-120) as part of the ClarIDHy Phase 3 clinical study. Data from that clinical trial were presented at the 2019 European Society for Medical Oncology (ESMO) Congress.

The Oncomine Precision Assay is a next-generation sequencing (NGS) assay that is used to detect key biomarkers from formalin-fixed paraffin-embedded (FFPE) tissue or liquid biopsy specimen. The assay contains more than 50 cancer-related biomarkers and, when run on the Genexus System, features an automated workflow with a one-day turnaround time and the lowest sample requirements on the market for detection of both DNA and RNA variants. The latest CDx agreement is the first that leverages the Oncomine Precision Assay and the Genexus System, which were introduced to the market in November 2019.