US pharmaceutical and biotechnology company Thermo Fisher Scientific (NYSE: TMO) has received marketing approval from the US Food and Drug Administration (FDA) for its Ion Torrent Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals’ Voranigo (vorasidenib) tablets.
Voranigo, the first and only targeted therapy for patients with grade 2 IDH mutant glioma, is an IDH1 and IDH2 inhibitor designed for the treatment of adult and pediatric patients aged 12 and above with Grade 2 astrocytoma or oligodendroglioma, harboring an IDH1 or IDH2 mutation, following various surgical procedures. The Ion Torrent Oncomine Dx Target Test, a next-generation sequencing (NGS) CDx, is utilized to detect IDH mutation status in glioma patients, determining their suitability for Voranigo treatment.
The Oncomine Dx Target Test, which can provide biomarker results for multiple targeted therapies from a single sample, has previously been approved for indications in non-small cell lung cancer (NSCLC), cholangiocarcinoma (CCA), medullary thyroid cancer (MTC), and thyroid cancer (TC).- Flcube.com
