Oncomine Dx Target Test Aids in the Selection of NSCLC Targeted Therapies

Innovations and advancement in multiplex genotyping and high-throughput genomic profiling by next-generation sequencing (NGS) is helping advance personalized precision medicine in oncology.

On June 22, 2017, the U.S. Food and Drug Administration (FDA) granted premarket approval to Thermo Fisher for its Oncomine Dx Target Test, the first FDA-approved test that can detect multiple gene mutations for lung cancer in a single test from a single tissue sample.

Today, lung cancer is the leading cause of cancer-related deaths in the U.S.1 For people battling NSCLC, time is critical and days matter. Now, thanks to next-generation gene sequencing and the Oncomine Dx Target Test, physicians in the U.S. can order a test to screen patient samples matching them to one of the targeted NSCLC therapies the test is indicated for which is done in days instead of weeks.

 “Screening samples one biomarker at a time takes critical time patients may not have," said Joydeep Goswami, president of clinical next-generation sequencing and oncology at Thermo Fisher. “Our new Oncomine Dx Target Test returns results in days, helping physicians rapidly develop treatment plans for the most common form of lung cancer."

Specifically, the Oncomine Dx Target Test can detect multiple gene mutations for NSCLC in a single test from a single tissue sample, simultaneously evaluating 23 genes clinically associated with NSCLC. The recent FDA approval includes three genes for which the results can be used to identify patients who may be eligible for treatment for one of the following: the combined therapy of Tafinlar and Mekinist, XALKORI, or IRESSA.

The Oncomine Dx Target Test is available in the U.S. only. Thermo Fisher is now in discussions with several pharmaceutical companies looking to use the panel in the future for other FDA-approved targeted therapy applications beyond lung cancer. This effort is part of Thermo Fisher’s goal to help its customers advance precision medicine.

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Footnotes:

Tafinlar® and Mekinist® are registered trademarks of Novartis; XALKORI® is a registered trademark of Pfizer; and IRESSA® is a registered trademark of AstraZeneca.

1.  Non–Small Cell Lung Cancer: Epidemiology, Risk Factors, Treatment, and Survivorship; Julian R. Molina, MD, PhD, Ping Yang, MD, PhD, Stephen D. Cassivi, MD, Steven E. Schild, MD, and Alex A. Adjei, MD, PhD

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 (FFPE) tissue samples.

The Oncomine Dx  Target Test is for In Vitro Diagnostic Use.