FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple NSCLC Therapies
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 that 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: the combined therapy of dabrafenib (Tafinlar) and trametinib (Mekinist); crizotinib (Xalkori); or gefitnib (Iressa). With this test, physicians can now match patients to these therapies in days instead of several weeks—the expected wait time when screening samples one biomarker at a time.
“For people battling non–small cell lung cancer, time is critical and days matter” said Joydeep Goswami, President of Clinical Next-Generation Sequencing and Oncology at Thermo Fisher. “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.”
LabCorp's Diagnostics and Covance Businesses, NeoGenomics Laboratories, and Cancer Genetics, Inc, are among the first laboratories that will offer the Oncomine Dx Target Test as a service to oncologists. 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.
Thermo Fisher developed the Oncomine Dx Target Test in collaboration with Novartis and Pfizer. It is based on Thermo Fisher's Ion AmpliSeq technology, which enables screening of tumor samples for multiple genetic markers with 10 nanograms of nucleic acid. Returning results using such a small amount of formalin-fixed, paraffin-embedded material is a critical advantage of the test, since samples from patients with NSCLC are often limited in quantity.
More information about the Oncomine Dx Target Test is available at www.thermofisher.com/oncomine-dxtarget.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
