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Oncomine Universal Dx submitted for PMA

Nov. 14, 2016Thermo Fisher Scientific has filed the final module of a premarket approval application with the Food and Drug Administration for its Oncomine Universal Dx test, a multigene, next-generation-sequencing–based assay for non-small cell lung cancer.

If approved, the universal gene panel could be the first of its kind in the United States, according to a company statement, and would serve as a companion diagnostic used to select patients for specific NSCLC therapies. The test would also be accessible to global pharmaceutical companies for ongoing development of therapeutic drugs.

The test is designed to simultaneously screen patient tumor samples for multiple gene variants with a single test, minimizing the need to perform numerous sequential tests that identify individual biomarkers one at a time. Sequential testing is difficult in NSCLC cases. Samples are often limited and can create the need for additional invasive and sometimes dangerous biopsies if the tissue is depleted before a complete genetic profile is obtained. The Oncomine Universal Dx test can return genetic data in less than five days using 10 ng of DNA.

The Oncomine Universal Dx test has been optimized as part of Thermo Fisher’s collaboration with Novartis and Pfizer aimed at driving a paradigm shift in the way cancer patients are selected for drug therapies and the speed at which new NSCLC drugs are developed and registered. Thermo Fisher’s PMA submission includes clinical and analytical claims associated with NSCLC biomarkers and comes after the successful completion of clinical trials using patient samples provided by Novartis and Pfizer.

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