MILFORD, Mass., Nov. 11, 2016 /PRNewswire/ -- SeraCare Life Sciences, a leading partner to global in vitro diagnostics manufacturers and clinical laboratories, announced today at the Association for Molecular Pathology 2016 annual meeting the launch of two new reference materials for genomic analysis of solid tumors. Seraseq Tumor Mutation DNA Mix v2 (RUO-GMP) and Seraseq FFPE Tumor KRAS Reference Material Kit are highly accurate, precise, and consistent materials that can help laboratories evaluate the performance of their clinical oncology assays.
Detection of cancer-relevant mutations using technologies such as NGS or qPCR is challenging for a variety of reasons: Variants may be present at allele frequencies approaching the lower limit of detection (LoD); variation that affects results is difficult to trace and often arises across complex workflows; and assays will have different sensitivities across different types of mutations. Additionally, the use of residual patient samples or cell lines that are positive for a single mutation as reference materials is not cost effective for highly multiplexed assays that can detect many biomarkers in a single run. Therefore it is essential for clinical labs and in vitro diagnostic developers to have a reliable source of robust tools to ensure test quality. The Seraseq Tumor Mutation DNA Mix v2 contains 40 clinically actionable and analytically challenging mutations at 10%, 7%, and 4% Minor Allele Frequency (MAF), and is manufactured under GMP to guarantee lot-to-lot consistency. This highly multiplexed material contains the most challenging and relevant variant types in a reference material on the market, including structural variants with defined intronic breakpoints, insertion/deletion mutations, and variants present in repetitive sequence contexts. The product is also available in a Tri-Level format, where the 40 mutations are distributed across the three MAFs, in a single vial.