Thermo Fisher Submits Premarket Approval Application to FDA for Sequencing-Based Companion Dx

Nov 14, 2016

NEW YORK (GenomeWeb) – Thermo Fisher Scientific has submitted a premarket approval application to the US Food and Drug Administration for a next-generation sequencing-based companion diagnostic, the company said today.

The firm submitted an application for its Oncomine Universal Dx test for non-small cell lung cancer that it developed in partnership with Novartis and Pfizer. The test will use the Ion AmpliSeq technology and run on the Ion Torrent PGM Dx system.

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