SeraCare Launches New Quantitative Reference Materials for NGS‐Based Tumor Profiling Assays

Milford, Massachusetts, Oct 13, 2015 ‐ SeraCare Life Sciences, a leading partner to global in vitro diagnostics manufacturers, announced today that the company’s precision medicine business unit has launched its second product in a growing line of reference materials for next‐generation sequencing (NGS)‐based tumor profiling assays. The Seraseq™ Solid Tumor Mutation Mix‐I (AF1‐10) contains the same mixture of mutations in key oncogenes and tumor suppressor genes as in the previously launched AF20 mix, but is offered at five additional allele frequencies.

By offering a set of material at 10%, 8%, 5%, 3% and 1% allele frequency, this product enables laboratories to test their lower limit of variant frequency against a known and well‐characterized reference material. While clinical laboratories that have adopted somatic mutation detection by next generation sequencing typically maintain their own mixtures of diluted cell‐line DNA, they will not have the breadth of mutations, mutation types, or the ability to probe the lower limit of variant frequencies they can detect with their assays.

“SeraCare demonstrates with the SeraseqTM Solid Tumor Mutation Mix‐I (AF1‐10) our ability to accurately ‘tune’ mutations to specific allelic frequencies to enable individual laboratories to determine their true lower level limit of detection in their tumor profiling assays,” says Russell Garlick, Chief Scientific Officer at SeraCare. “Determining this lower limit across many mutation types is important as a given sample may vary widely in tumor cellularity and somatic mutation profile.”

Similar in design to the SeraseqTM Solid Tumor Mutation Mix‐I (AF20), the AF1‐10 mix includes 26 mutations in major cancer ‘hotspot’ genes, and is quantitated using digital PCR to ensure accuracy. It is stable for two years under recommended storage conditions and can undergo ten freeze‐thaw cycles without any degradation in performance.

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).