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FDA Approves Thermo Fisher’s Oncomine™ Dx Target Test as CDx for VORANIGO® to Treat IDH-Mutant Gliomas

NextEdge Admin

22 Oct 2024

2 min 22 sec

Thermo Fisher Scientific has secured U.S. Food and Drug Administration (FDA) approval for its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic (CDx) for identifying patients eligible for VORANIGO® (vorasidenib) tablets by Servier Pharmaceuticals. VORANIGO, the first targeted therapy for Grade 2 IDH-mutant gliomas, treats adults and children (12+) with astrocytoma or oligodendroglioma harboring IDH1 or IDH2 mutations after surgery. This milestone offers new hope for a challenging brain cancer with limited treatment options.

Gliomas account for 81% of malignant brain tumors, with approximately 20% carrying IDH mutations, making testing essential for precise treatment. The National Comprehensive Cancer Network (NCCN) guidelines recommend IDH mutation testing for all glioma patients to inform diagnosis, prognosis, and therapy choices. VORANIGO’s approval reinforces the importance of identifying these mutations.

The Oncomine Dx Target Test, already approved for non-small cell lung cancer, cholangiocarcinoma, medullary thyroid cancer, and thyroid cancer, provides multiple biomarker results from a single sample, expediting personalized treatment matching.

"VORANIGO offers a long-overdue treatment advance for patients with grade 2 IDH-mutant gliomas," said David K. Lee, CEO of Servier Pharmaceuticals. Kathy Davy, president of clinical next-generation sequencing at Thermo Fisher, emphasized that the approval aligns with their mission to accelerate access to precision medicine.

Available in 19 countries, the Oncomine Dx Test will be expanded further with the Oncomine Dx Express Test on the Ion Torrent Genexus™ Dx System, delivering same-day results in CE-mark countries to streamline patient care.