Milford, Massachusetts, November 11, 2016 - 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 (RUOGMP) 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.
The Seraseq FFPE Tumor KRAS Reference Material Kit v1 contains seven mutations that affect codons 12 and 13 of the KRAS gene, which account for approximately 97% of all characterized KRAS mutation subtypes. All variants are present at around a 5% MAF in order to rigorously challenge the LoD for common, commercially available KRAS tests. Cells carrying these mutations are provided as formalin-fixed, paraffin-embedded sections similar to those received by anatomic pathology and clinical molecular diagnostic labs; this allows monitoring of variation throughout all steps of the workflow, including pre-analytic processes.
"We are very pleased to introduce these new reference materials to our partners and customers who are developing, validating, and running clinical oncology molecular tests," says Russell Garlick, CSO at SeraCare. "Along with our other Seraseq reference materials as well as our iQ NGS QC Management software solution, they will help ensure laboratories are able to focus on their patients, and can implement a highly effective, cost-efficient QC strategy."
About SeraCare Life Sciences Inc.
SeraCare enables the promise of precision medicine by advancing the understanding of disease and providing assurance of the diagnostic result. Our innovative tools and technologies not only ensure the safe, effective, and accurate performance of diagnostic assays but also establish a framework for regulating, compiling, and interpreting data from precision diagnostics. Our portfolio includes a broad range of products such as quality control technologies, disease-state specimens and tissues for research and development, processed biological materials, and immunoassay reagents. For more information, please visit www.seracare.com and follow SeraCare on Twitter (@SeraCare).