CARLSBAD, Calif.--(BUSINESS WIRE)--The newly 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 with the quality and performance needed for the clinical laboratory.
Compared to other molecular diagnostic testing methods, such as qPCR or Sanger sequencing, 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.
“With this new CE-IVD Oncomine Solid Tumor DNA kit, we can enable the screening of the actionable mutations involved in colon and lung cancer with the high level performance that is required in a clinical laboratory setting,” said Nicola Normanno, M.D., Chief of the Laboratory Of Pharmacogenomics at the Centro Ricerche Oncologiche in Mercogliano, Avellino, Italy.
“The release of the CE-IVD Oncomine Solid Tumour DNA kit is a major advance for clinical service provision insofar as it will dramatically reduce in house validation for accreditation purposes and will allow the implementation of accurate and reproducible screening of pertinent mutations in colon and lung cancers,” said Professor Orla Sheils from Trinity College, Dublin.
“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,” said Mark Stevenson, president of Life Science Solutions at Thermo Fisher Scientific. “Together in partnership with our oncology consortiums that include representation of both pharmaceutical companies and leading clinical laboratories, we intend to continue expansion of our regulated NGS oncology offering over time to meet the needs of our clinical customers and the patients that they serve.”
* The OncoNetwork Consortium members include these researchers:
Pierre Laurent-Puig1, Cecily Vaughn2, Ludovic Lacroix3, Marjolijn Ligtenberg4, Bastiaan Tops4, Christoph Noppen5, Henriette Kurth5, Nicola Normanno6, Aldo Scarpa7, Ian Cree8, Orla Sheils9, Harriet Feilotter10, José Carlos Machado11, Jose Costa11, Kazuto Nishio12
1 Université Paris Descartes, Paris, France
2 ARUP- Institute for Clinical and Experimental Pathology, Utah, USA
3 Institut Gustave Roussy, Paris, France
4 Radboud University Nijmegen Medical Centre, The Netherlands
5 VIOLLIER AG, Basel, Switzerland
6 Centro Ricerche Oncologiche Mercogliano, Avellino, Italy
7 ARC-NET University of Verona, Italy
8 Warwick University Medical School, United Kingdom
9 Trinity College Dublin, Ireland
10 Queen’s University, Ontario Canada
11 IPATIMUP Medical Faculty of Porto, Portugal
12 Faculty of Medicine, Kinki University, Osaka, Japan
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