Minute Insight: Thermo Fisher Gets FDA OK On Cancer Companion Diagnostic
The US FDA has approved additional indications for Thermo Fisher Scientific’s Oncomine Dx Target, allowing the companion diagnostic to be used to detect more varieties of lung and thyroid cancer.
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US FDA recently approved Oncomine Dx Target Test, the first multi-drug next-generation sequencing test made by Thermo Fisher Scientific. The test is a companion diagnostic for lung-cancer drugs made by Novartis and Pfizer, and the diagnostic company is looking to expand its partnership to other pharma companies.
NWW: Studies Back Nevro Pain Treatment, FTC Blesses Resonetics Nitinol Deal, Genetic Test Identifies Best RDN Patients
This week, studies supported Nevro’s spinal cord stimulation therapy and a VRx system that helps reduce pain; the American Medical Association found inconsistent insurance coverage of digital therapeutics; and Geneticure announced a cheek-swab test to identify which patients are most likely to benefit from renal denervation.
Hyman, Phelps & McNamara partner Allyson Mullen has helped many manufacturers get breakthrough device designations from the US FDA. In this conversation, she shares her insights on the process, the best way to prepare, and why some designated devices might be slow to make it to shelves.