SeraCare Precision Medicine Business Unit Launches First Product

The new precision medicine business unit of SeraCare Life Sciences, Milford, Mass, has launched its first product, the Seraseq solid tumor mutation mix I. The biosynthetic reference material is designed to evaluate the performance of next-generation-sequencing (NGS)-based tumor profiling assays. Containing a mixture of mutations in key oncogenes and tumor suppressor genes, the product is intended as a quality material for translational and disease research testing. In addition, it permits laboratories to monitor library preparation, sequencing, and variant allele detection under a given set of bioinformatics parameters.

Clinical laboratories that have adopted NGS for somatic mutation detection typically maintain their own prediluted mixtures of characterized cell-line DNA. Such a practice is labor intensive, and may also lead to mixtures that are inconsistently characterized and of unknown stability and variability. A well-designed quality control program is critical for providing reliable results obtained for unknown specimens. The use of independent reference products may provide valuable information concerning assay sensitivity and bioinformatics pipeline analysis.

“This technology allows almost unlimited breadth of mutations and can be accurately ‘tuned’ to specific allelic frequencies because we’ve incorporated digital polymerase chain reaction (PCR) in the manufacturing,” says Russell Garlick, chief scientific officer at SeraCare. “With this product, we can partner with in vitro diagnostics developers and clinical labs to offer a powerful performance tracking tool for their NGS tumor profiling assays.”

Seraseq solid tumor mutation mix is a mixture of biosynthetic target genes with specific engineered mutations in a wild-type background of well-characterized genomic DNA, and is compatible with all major cancer hotspot oncology panels and NGS platforms on the market today. This first version includes 26 major cancer hotspot genes, all at 20% allelic frequency and quantitated using digital PCR to ensure highest accuracy. It is stable for 2 years under recommended storage conditions, and can undergo 10 freeze-thaw cycles without any degradation of performance.

“We are fully dedicated to building on our investments in precision driven diagnostics through technology developments and strategic partnerships,” says Charlie Mamrak, chief executive of SeraCare. “The Seraseq solid tumor mutation mix is just the first of many precision medicine products that SeraCare has in development, and we look forward to continuing our commitment to bringing new technologies and tools to our customers.”

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