Companion Diagnostic Test to Screen Multiple Lung Cancer Therapies Receives FDA Approval
Posted: Wednesday, July 12, 2017
On June 22, the U.S. Food and Drug Administration (FDA) granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing–based test, which simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non–small cell lung cancer (NSCLC).
The Oncomine Dx Target Test simultaneously evaluates 23 genes clinically associated with NSCLC. Following FDA approval, results from analysis of three of these genes can now be used to identify patients who may be eligible for treatment with one of the following: combined therapy of dabrafenib, trametinib, crizotinib, and gefitinib. With this test, physicians can now reportedly match patients to these therapies in days instead of several weeks, which is often how long it takes when screening samples one biomarker at a time.
All tests will be run on Thermo Fisher’s Ion PGM Dx System, which received FDA 510(k) clearance in parallel for use on formalin-fixed, paraffin-embedded tissue samples.