FDA approves diagnostic that simultaneously screens for multiple lung cancer types

The FDA said today that it awarded premarket approval to Thermo Fisher Scientific’s (NYSE:TMO) next-gen sequencing-based test that can simultaneously screen tumor samples for biomarkers associated with 3 approved therapies for non-small cell lung cancer.
The company’s Oncomine Dx Target Test evaluates 23 genes associated with non-small cell lung cancer. The tests results could help physicians match patients to therapies in days. Traditionally, that process can take several weeks since clinicians are forced to screen samples for individual biomarkers.
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Source: Mass Device - June 23, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Diagnostics Food & Drug Administration (FDA) Oncology Pharmaceuticals Regulatory/Compliance Respiratory Wall Street Beat Novartis Pfizer Thermo Fisher Scientific Source Type: news