Precision Medicine Target Testing
Matching Lung Cancer Patients with Multiple Approved Therapies
In June 2017, the U.S. Food and Drug Administration (FDA) granted premarket approval for the first next-generation sequencing (NGS)-based test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non-small cell lung cancer (NSCLC). Lung cancer is the leading cause of cancer-related deaths in the U.S., with NSCLC accounting for 85 percent of all lung cancers.
The Oncomine Dx Target Test is the result of a unique 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 (FFPE) tissue material is a critical advantage of the test since sample quantities from patients with NSCLC are often limited.
The Oncomine Dx Target Test simultaneously evaluates 23 genes clinically associated with NSCLC. Results from the 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 Tafinlar and Mekinist, XALKORI, or IRESSA. With this test, physicians can now match patients to these therapies in days instead of several weeks, which it often takes 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."
"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. "We have 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."