Thermo Fisher gets FDA approval for NSCLC biomarker test

25 June 2017 (Last Updated June 25th, 2017 18:30)

Thermo Fisher Scientific has received the US Food and Drug Administration (FDA) approval for its next-generation sequencing (NGS) based test as a companion diagnostic for various non-small cell lung cancer (NSCLC) therapies.

Thermo Fisher Scientific has received the US Food and Drug Administration (FDA) approval for its next-generation sequencing (NGS) based test as a companion diagnostic for various non-small cell lung cancer (NSCLC) therapies.

The Oncomine Dx Target Test is designed to simultaneously screen tumour samples for biomarkers associated with three FDA-approved NSCLC therapies.

The test simultaneously analyses 23 genes, of which three can now be used to identify patients who are eligible for potential treatment with the combined therapy of Tafinlar and Mekinist, XALKORI or IRESSA.

Contrary to other tests, which screen one biomarker at a time, the test is said to allow physicians to match patients to the therapies within days instead of weeks.

Thermo Fisher clinical next-generation sequencing and oncology president Joydeep Goswami said: "For people battling non-small cell lung cancer, time is critical and days matter.

"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 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."

Initially, the test is being offered by LabCorp's Diagnostics and Covance Businesses, NeoGenomics Laboratories and Cancer Genetics using Thermo Fisher's FDA 510(k) cleared Ion PGM Dx System.

Goswami further noted: "Thermo Fisher has entered into discussions with several pharmaceutical companies looking to use the panel for FDA-approved targeted therapy applications beyond lung cancer.”

Developed in partnership with Novartis and Pfizer, the test is based on Thermo Fisher's Ion AmpliSeq technology to facilitate tumour sample screening for several genetic markers with 10ng of nucleic acid, which is considered a benefit as samples from NSCLC patients are usually limited.


Image: FDA approves the Oncomine Dx Target Test. Photo: courtesy of PRNewsfoto/Thermo Fisher Scientific Inc.