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FDA Clears Thermo Fisher NGS Companion Diagnostic for Three NSCLC Treatments

05:20 EDT 23 Jun 2017 | Genetic Engineering News

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, president of clinical next-generation sequencing and oncology at Thermo Fisher. "The Oncomine Dx Target Test rapidly guides oncologists toward the right ...

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