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Thermo Fisher Scientific Gets CE-IVD Mark for NGS Cancer Test

NEW YORK (GenomeWeb) — Thermo Fisher Scientific announced today that it has received CE-IVD marking for its Oncomine Dx Target Test.

The next-generation sequencing-based test is designed to detect 46 cancer-driver gene variants associated with approved and investigational targeted therapies for solid tumors — including ones against EGFR, BRAF, KRAS, and ERBB2 mutations, and ALK, ROS1, RET, NTRK, and MET fusions. It is also validated as a companion diagnostic for certain approved non-small cell lung cancer therapies including ALK, ROS1, and BRAF kinase inhibitors, as well as EGFR exon 19 deletions and L858R tyrosine kinase inhibitors.

The test was approved as a companion diagnostic by the US Food and Drug Administration in mid-2017. It is currently offered by several national reference laboratories including LabCorp's Diagnostics and Covance businesses, Quest Diagnostics, Cancer Genetics, and NeoGenomics Laboratories, and has received positive coverage decisions from the Centers for Medicare & Medicaid Services and a number of private payors.

"We are encouraged by the number of national reference laboratories that are now providing Oncomine Dx Target Test to oncologists," Joydeep Goswami, president of clinical next-generation sequencing at Waltham, Massachusetts-based Thermo Fisher, said in a statement. "This indicates a shift from the single biomarker testing approach to a more efficient testing regime that saves precious time for their cancer patients."