The world leader in serving the scientific and medical community, Thermo Fisher Scientific recently announced that they received CE-IVD marking for their Oncomine Dx Target Test, which is the next-generation sequencing (NGS)-based solution that screens biomarkers across solid tumors. This test is CE marked as an in vitro diagnostic test for detection of 46 cancer-driver gene variants. Those gene variants are associated with approved and investigational targeted therapies for solid tumors - including ones against EGFR, BRAF, KRAS, and ERBB2 mutations, and ALK, ROS1, RET, NTRK, and MET fusions.
It is also validated as a companion diagnostic (CDx) for certain approved non-small cell lung cancer (NSCLC) therapies including ALK, ROS1, and BRAF kinase inhibitors, as well as EGFR exon 19 deletions and L858R tyrosine kinase inhibitors. The test that is designed to return results with as little as 10 nanograms of nucleic acid, received approval from the U.S. Food and Drug Administration (FDA) as a CDx for NSCLC in 2017. The company highlighted Oncomine Dx Target test during the European Society for Medical Oncology (ESMO) Congress that was held in Munich, Germany from October 19-23.
The test is now offered by several national reference laboratories such as LabCorp's Diagnostics and Covance businesses, and Quest Diagnostics; it has received positive coverage decisions from the Centers for Medicare & Medicaid Services (CMS) and a number of private payers.
According to Joydeep Goswami, president of clinical next-generation sequencing at Waltham, Massachusetts-based Thermo Fisher, "Obtaining the CE-IVD Mark represents a significant step in our endeavor to democratize NGS testing and precision oncology across the globe. We are encouraged by the number of national reference laboratories that are now providing Oncomine Dx Target Test to oncologists." At the same time, Fernando López-Ríos, director of the targeted therapies laboratory at the Hospital Universitario HM Sanchinarro in Madrid, Spain said that having access to this Target Test will improve their ability to care for cancer patients by allowing them to have multiple therapeutic targets in one test requiring very little tissue.