Source: Clinical Laboratory News
Thermo Fisher Scientific has received approval from the Food and Drug Administration (FDA) for its Oncomine Dx Target test, a first-of-its-kind next-generation- sequencing (NGS)-based companion diagnostic that detects genetic mutations in patients with non-small cell lung cancer (NSCLC). The test simultaneously screens tumor samples and evaluates 23 genes associated with NSCLC. Results from analyzing three of these genes may help identify patients who could benefit from treatment with one of three FDA-approved NSCLC therapies: combination Tafinlar (dabrafenib) and Mekinist (trametinib), Xalkori (crizotinib), or Iressa (gefitinib). The Oncomine Dx Target test delivers results within 4 days and runs on Thermo Fisher’s Ion PGM Dx system. It is based on the company’s Ion AmpliSeq technology, which simultaneously screens samples for multiple biomarkers using 10 ng of nucleic acid. Thermo Fisher developed the assay in collaboration with Novartis and Pfizer, and will initially offer the test in laboratories such as LabCorp and its Covance business.