NEW YORK (GenomeWeb) – Thermo Fisher Scientific has received CE-IVD marking for its next-generation sequencing-based Oncomine Solid Tumor Fusion Transcript kit.
The kit makes use of the Ion AmpliSeq technology and detects rearrangements involving ALK, ROS-1, RET, and NTRK1 genes. Researchers within Thermo's OncoNetwork Consortium worked with Thermo Fisher to develop the kit and validate it for lung cancer.
The kit is amenable for use with formalin-fixed paraffin-embedded tissue and requires as little as 10 ng of RNA.
"The comprehensive content, selected to align with patient prognosis and therapy decision guidance, represents the new generation of genetic tests for colon and lung cancer patients," Jose Costa, from the IPATIMUP Medical Faculty of Porto, Portugal, said in a statement.
The fusion panel is the second Oncomine panel to receive CE-IVD marking. In January, Thermo Fisher received CE-IVD marking for its Oncomine Solid Tumor DNA panel, which focuses on lung and colon cancers. In today's statement, Mike Nolan, vice president and general manager of Oncology at Thermo Fisher, said that when the Oncomine kits are used together, "mutations can be identified simultaneously with fusion transcripts, all in a single streamlined procedure."
The company also has a more comprehensive Oncomine panel for research use only, and is developing a companion diagnostic based on markers within that panel in collaboration with GlaxoSmithKline and Pfizer and plans to submit it to the US Food and Drug Administration for premarket approval. In addition, it is working with the National Cancer Institute to validate an Oncomine panel for the NCI-MATCH trial.
The OncoNetwork Consortium is a Thermo Fisher-coordinated effort to develop AmpliSeq cancer panels and consists of researchers from ARC-NET University of Verona, Italy; ARUP in Salt Lake City; Cancer Research Center of Mercogliano in Italy; the Institut Gustave Roussy in France; IPATIMUP Medical Faculty of Porto, Portugal; Kinki University in Osaka, Japan; Queen's University in Ontario; Radboud University Medical Center in the Netherlands; Trinity College Dublin, Ireland; the University of Warwick in the UK; the University Paris Descartes Center in France; and the genetics and molecular biology division of pharmaceutical company Viollier in Switzerland.