FDA Approves First NGS Oncology Companion Dx for Multiple Therapies

In May, the U.S. Food and Drug Agency (FDA), the agency known for its stinginess in approving new products, broke new ground by approving Merck’s Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor, a cancer drug administered on the basis of a tumor’s genomic features rather than its location in the patient’s body. Barely a month later, the agency raised eyebrows again, this time on the diagnostic testing front, by issuing its first-ever approval for a next-generation sequencing (NGS) oncology panel for multiple therapies.

On June 22, the FDA issued premarket approval to Oncomine Dx Target Test, Thermo Fisher Scientific’s NGS-based companion diagnostic for nonsmall cell lung cancer (NSCLC) diagnostic that simultaneously screens for biomarkers associated with three FDA-approved therapies. The test was approved to detect multiple gene mutations (BRAF, ROS1, and EGFR) from a single tissue specimen. The results of the test aid in selecting targeted therapies, including IRESSA (gefitinib) for EGFR L858R and Exon 19 deletions, Tafinlar + Mekinist (dabrafenib in combination with trametinib) for BRAF V600E, or XALKORI (crizotinib) for ROS1 fusion.

Thermo Fisher says that the test kit enables quicker matching for targeted therapies, through a single test rather than sequential testing. The company also says the test will be available in the U.S. beginning in July 2017. LabCorp’s Diagnostics and Covance Businesses, NeoGenomics Laboratories, and Cancer Genetics, are the first laboratories offering the test. The test is run on Thermo Fisher’s Ion PGM Dx System, which received FDA 510(k) clearance in parallel for use on formalin- fixed, paraffin-embedded (FFPE) tissue samples.

"This first iteration of the test is just the beginning since the diagnostic claims of the Oncomine Dx Target Test may be expanded in the future based on the existing panel," said Joydeep Goswami, Thermo Fisher’s president of clinical next-generation sequencing and oncology, in a statement. "Thermo Fisher has entered into discussions with several pharmaceutical companies looking to use the panel for FDA-approved targeted therapy applications beyond lung cancer."

The Oncomine Dx Target Test also currently targets an additional 20 NSCLC-associated gene variants currently being investigated in clinical trials that may be actionable in the future. The company expects that as other drugs are approved, the FDA will expand approvals on the panel.

Takeaway: FDA-approved NGS-based companion diagnostics are entering the commercial market both as kits and as laboratory-developed tests.


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