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.
Analysis of 3 of the 23 genes can be used to identify patients who may be eligible for 1 of 3 different treatments, according to the approval.
“For people battling non-small cell lung cancer, time is critical and days matter,” Joydeep Goswami, president of clinical next-generation sequencing & oncology at Thermo Fisher, said in prepared remarks. “The Oncomine Dx Target Test rapidly guides oncologists toward the right targeted therapy, with the goal of improving patient outcomes and the cost-efficiency of treatments.”
The diagnostic test won 510(k) clearance in parallel with Thermo Fisher’s Ion PGM Dx System.
“This first iteration of the test is just the beginning since the diagnostic claims of the Oncomine Dx Target Test may be expanded in the future based on the existing panel,” Goswami added. “Thermo Fisher has entered into discussions with several pharmaceutical companies looking to use the panel for FDA-approved targeted therapy applications beyond lung cancer. Expanding the range of clinically actionable information is part of the company’s goal to help our customers advance precision medicine.”
Thermo Fisher worked with Novartis (NYSE:NVS) and Pfizer (NYSE:PFE) to develop the Oncomine diagnostic test.
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