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FDA Approves Thermo Fisher Oncomine Dx Target Test as CDx for Servier's Voranigo Brain Cancer Drug

NEW YORK – Thermo Fisher Scientific said Monday that its Ion Torrent Oncomine Dx Target test has received approval from the US Food and Drug Administration for use as a companion diagnostic to identify patients eligible for treatment with Servier Pharmaceuticals' Voranigo (vorasidenib), an FDA-approved drug for grade 2 IDH-mutant glioma.

The drug is approved for use in adult and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, subtotal resection, or gross total resection.

The FDA approval expands the clinical indications for the Oncomine Dx Target test, which was previously approved for non-small cell lung cancer (NSCLC), cholangiocarcinoma (CCA), medullary thyroid cancer (MTC), and thyroid cancer (TC).

As a distributable companion diagnostic, Oncomine Dx can deliver biomarker results for multiple targeted therapies from one sample, Thermo Fisher said.

According to the company, Oncomine Dx is currently approved and reimbursed by government and commercial insurers in 19 countries, including the US, Japan, South Korea, and countries across Europe and the Middle East.

Following the latest FDA approval, Thermo Fisher said it will continue to collaborate with Servier on an additional companion diagnostics test using the Ion Torrent next-generation sequencing platform. Dubbed Oncomine Dx Express test, that assay promises to return results within a day to help accelerate the pace with which patients can be matched with treatments based on their genomic results, the company noted.