Thermo Fisher Scientific releases new CE-IVD tumor panel for next generation sequencing

The recently released CE-IVD Oncomine Solid Tumor DNA kit from Thermo Fisher Scientific enables highly accurate and reliable multiplexed sequencing of formalin-fixed, paraffin embedded (FFPE) tumor samples in the clinical laboratory.

Next-generation sequencing (NGS) can assess a broader range of genes in a single test. Based on the Ion Torrent AmpliSeq Technology, the kit allows detection of single nucleotide somatic changes, inversions, insertions, and deletions using as little as 10ng of FFPE DNA, enabling laboratory clinicians to analyze samples that may contain partially degraded or limited tumor material, and generate reportable results from more samples than previously possible with lower acceptance thresholds for FFPE tumor DNA.

The panel was verified by leading clinicians from the OncoNetwork Consortium with a focus on colon and lung cancer. Marked for in vitro diagnostic use in the European Union, the kit captures regions of human somatic variants (deletions, insertions, inversions, and substitutions) present in selected regions of cancer-related genes (EGFR, ALK, ERBB2, ERBB4, FGFR1, FGFR2, FGFR3, MET, DDR2, KRAS, PIK3CA, BRAF, AKT1, PTEN, NRAS, MAP2K1, STK11, NOTCH1, CTNNB1, SMAD4, FBXW7, TP53) for analysis using NGS technology.

“The development and commercialization of the CE-IVD Oncology Solid Tumor DNA kit in the European Union is representative of our continued commitment to enabling our customers to advance clinical oncology care while meeting regional regulatory requirements,” says Mark Stevenson, president of Life Science Solutions at Thermo Fisher Scientific.