FDA approved Thermo Fisher Scientific’s Oncomine™ Dx Target Test as the first next-generation sequencing (NGS)-based companion diagnostic that screens tumor samples against panels of biomarkers to identify patients who may respond to one of three different treatments for non-small cell lung cancer (NSCLC).

The Oncomine Dx Target Test exploits high-throughput, parallel-sequencing technology to screen tumor samples for 23 NSCLC genes, to identify patients who may be eligible for therapy using the Novartis drug combination Tafinlar® (dabrafenib) plus Mekinist® (trametinib) for tumors with BRAF V600E mutations, or treatment with Pfizer’s Xalkori®  (crizotinib) for ROS1 fusions, or therapy using AstraZeneca’s Iressa® (gefitinib) for EGFR L858R mutation and and Exon 19 deletions.

“For people battling non-small cell lung cancer, time is critical and days matter,” said Joydeep Goswami, Ph.D., president of clinical NGS 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.”

FDA today separately approved the Tafinlar plus Mekinist combination for treating patients with BRAF V600E mutated NSCLC tumors screened using the Oncomine Dx Target Test.

Thermo Fisher developed the Oncomine Dx Target Test in collaboration with Novartis and Pfizer. The assay is based on Thermo Fisher's Ion AmpliSeq technology, which can screen tumor samples for multiple genetic markers using 10 nanograms of nucleic acid. FDA has in parallel granted 510(k) clearance to Thermo Fisher’s Ion PGM Dx System to run the oncomine Dx tests on formalin-fixed paraffin-embedded (FFPE) tissue samples.

Thermo Fisher is looking to expand utility of the test, which also targets 20 NSCLC-associated gene variants that are currently being evaluated in clinical trials. “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,” Dr. Goswami added. “Thermo Fisher has entered into discussions with several pharmaceutical companies looking to use the panel for FDA-approved targeted therapy applications beyond lung cancer.”








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