SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers, and TOMA Biosciences, a genomics company providing the most effective sequencing solution to identify clinically meaningful changes in the DNA of cancer tumors, announce today a co-development partnership during the 2016 American Association of Cancer Research in New Orleans.
Under the terms of the agreement, SeraCare will provide TOMA Biosciences access to their Seraseq™ Solid Tumor Mutation Mix reference material technology to support the development and validation of the TOMA OS-Seq™ comprehensive solid tumor gene analysis kit, as well as their upcoming PlasmaSeq™ liquid biopsy test.
TOMA Bioscience’s OS-Seq proprietary technology permits researchers to evaluate in toto each gene in its panel for all mutation types, including Copy Number Alterations (CNAs), with a simplified single day library prep method.
The accurate detection of CNAs, single-nucleotide variants, insertion-deletion mutations, and DNA translocations requires well-characterized reference standard material to assist with both assay development and routine assay quality assurance.
The Seraseq Solid Tumor Mutation Mix technology offers the broadest selection of actionable and hard-to-sequence somatic variants at precise allelic frequencies within a well characterized reference genome background.
"Our Seraseq reference materials with a comprehensive and customizable set of mutations are ideally suited to the comprehensive nature of the TOMA OS-Seq reagent kit," said Federico Goodsaid, Ph.D., Vice President of Assay Development and Regulatory Affairs.
"More importantly, we share the vision of a strong quality and regulatory approach when bringing validated NGS-based tumor profiling assays to market."
"We are very excited to be working with TOMA Biosciences and supporting their innovative OS-Seq technology with our Seraseq technology," said Trevor Brown, Vice President of Precision Medicine at SeraCare. "
SeraCare has 30 years of experience providing high value tools for assay developers and clinical laboratories and strong experience with the 510k/IVD regulatory path." Our goal is to seek out mutually beneficial partnerships with NGS-based assay developers that leverage our ever growing pipeline of innovative tools supporting better data quality in precision diagnostics."
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 provide assurance of the safe, effective, and accurate performance of diagnostic assays but also establish a framework for regulating, compiling, and interpreting data from precision diagnostics.