New Quality Control Reference for Monitoring NGS-Based Tumor Profiling Assays

A newly released kit was designed to enable genomics researchers and drug developers to evaluate the performance of next generation sequencing (NGS)-based tumor profiling assays.

The SeraCare Life Sciences (Milford, MA, USA) Seraseq Solid Tumor Mutation Mix-I reference material 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. The reference matrix contains a mixture of mutations in key oncogenes and tumor suppressor genes and is intended as a quality control standard for translational and disease research testing.

This "for research use only" version includes 26 major cancer hotspot genes, all at 20% allelic frequency and quantified using digital PCR to ensure highest accuracy. The material is stable for two years under recommended storage conditions, and can undergo ten freeze-thaw cycles without any degradation of performance.

"SeraCare's extensive background and experience with the manufacture of quality reference and validation materials under cGMP ISO standards has enabled us to develop the Seraseq Solid Tumor Mutation Mix," said Dr. Russell Garlick, CSO at SeraCare. "This technology allows almost unlimited breadth of mutations and can be accurately "tuned" to specific allelic frequencies because we have incorporated digital PCR in the manufacturing. 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."

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