Thermo Fisher Scientific announced that its Ion Torrent Oncomine Dx Target Test received approval from the U.S. Food and Drug Administration (FDA) as a companion diagnostic (CDx). This approval identifies patients eligible for treatment with Servier Pharmaceuticals' VORANIGO (vorasidenib) tablets, the first targeted therapy for Grade 2 IDH-mutant glioma.
The approval is critical for patients with this aggressive brain cancer, which has seen limited treatment advances in nearly 25 years. The Oncomine Dx Target Test enables the identification of susceptible IDH1 or IDH2 mutations, which are essential for accurate treatment decisions and are recommended by NCCN Clinical Practice Guidelines in Oncology.
This expands the clinical indications for the Oncomine Dx Target Test, which is already approved and reimbursed in 19 countries, covering over 550 million lives globally, for various cancers including non-small cell lung cancer. Thermo Fisher will also collaborate on the Oncomine Dx Express Test, which can return results in as little as a single day, further accelerating patient access to optimal treatments.
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