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Thermo Fisher Makes Final Push For ‘Universal’ Lung-Cancer Companion Dx

The Oncomine Universal Dx looks in parallel for mutations on four genes associated with non-small cell lung cancer to help physicians pick between different drug options. Thermo Fisher has submitted its final PMA module to FDA.

DNA

Thermo Fisher Scientific Inc. is hoping for FDA approval by next June of what could be the first companion diagnostic to help pick the best option among multiple drugs rather than just inform a therapy decision for an individual drug.

The firm announced filing its final module of a PMA submission for Oncomine Universal Dx on Nov. 14

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