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Thermo Fisher Next-Gen Sequencing Panel Wins FDA Approval as Companion Test

NEW YORK (GenomeWeb) – The US Food and Drug Administration today approved Thermo Fisher Scientific's next-generation sequencing-based companion diagnostic that can analyze alterations in a panel of genes predictive of response across three non-small cell lung cancer treatments.

Thermo Fisher Scientific's Oncomine Dx Target Test can be used to identify best responders to AstraZeneca's EGFR inhibitor Iressa (gefitinib), Pfizer's ALK and ROS1 inhibitor Xalkori (crizotinib), and the combination of Novartis' MEK inhibitor Mekinist (trametinib) and RAF inhibitor Tafinlar (dabrafenib). The FDA-approved label for the test will indicate its use to predict which patients with EGFR mutations, ROS1 rearrangements, and BRAF mutations are likely to derive benefit from Iressa, Xalkori, and the Mekinist/Tafinlar combo, respectively.

The panel, however, gauges alterations in 23 genes in total. The test report will not only indicate whether patients have ROS1, EGFR, and BRAF alterations linked to the three FDA-approved treatments, but also the presence or absence of variants in other genes. [See premium story for in-depth coverage

The Oncomine Dx Target Test is based on Thermo Fisher's Ion AmpliSeq technology and will run on its PGM Dx System, for which the FDA also granted 510(k) clearance for analysis of formalin-fixed paraffin embedded tissue samples. The technology can gauge multiple genetic markers from 10 nanograms of DNA, a feature Thermo Fisher highlighted given the challenge of procuring large biopsy samples from advanced lung cancer patients.

Thermo Fisher's test is a kit that can be performed at different CLIA-certified, CAP-accredited labs. LabCorp's diagnostics and Covance businesses, NeoGenomics Laboratories, and Cancer Genetics are among the first labs with trained staff to offer the Oncomine Dx Target Test to ordering oncologists.

The NGS platform developer advanced the companion diagnostic in collaboration with Novartis and Pfizer. The inclusion of AstraZeneca's Iressa was the result of FDA's guidance to Thermo Fisher, a company spokesperson said.

This initial approval makes way for Thermo Fisher to quickly expand the indication of the panel into new markers predictive of drug response. The company is actively working with other drugmakers to expand the indications for the Oncomine Dx Target Test.