Swift Biosciences and SeraCare Partner on Circulating Tumor DNA Standards for NGS-Based Oncology Assays

Ann Arbor, Michigan and Milford, Massachusetts, Jan 28, 2016 - Swift Biosciences, developer of innovative technologies for genomics research, and SeraCare Life Sciences, a manufacturer and leading partner to global in-vitro diagnostics manufacturers, has announced a partnership to accelerate development of a novel circulating tumor DNA reference material. Circulating tumor DNA (ctDNA) detection, also called a ‘liquid biopsy’, is a needed application of next-generation sequencing (NGS) to detect cancer mutation signatures directly from blood plasma samples for patients with tumors that cannot be biopsied.

Seraseq™ ctDNA products are based upon patent-pending technology used to make circulating fetal DNA reference materials. Mixtures of DNA containing key somatic mutations at specific allelic frequencies are provided as stabilized material in a proprietary synthetic plasma matrix.

The first ctDNA reference material available for early access is a 9-mutation mixture at varying allele frequencies targeted from 5% down to 0.1%. The Seraseq circulating nucleic acid technology is robust and highly amenable to customization, supporting any number of mutations and allele frequencies as quantitated by digital PCR (dPCR). The combination of design and stabilization technology results in a highly precise and reproducible ‘ground truth’ material suitable for NGS and dPCR assay development and performance monitoring.

“Swift Biosciences has been instrumental in providing leading NGS-based assay results using their unique library construction enzymology and target enrichment chemistry”, said Russell Garlick PhD, CSO of SeraCare Life Sciences. “With Swift’s Accel-Amplicon™ Oncology panel, we have observed reliable and consistent results with our Seraseq ctDNA biosynthetics to allele frequencies below 1%.”

Swift Accel-Amplicon panels offer a streamlined workflow and all materials necessary for complete library construction, with the low input requirements necessary for materials such as ctDNA and FFPE samples. As use of liquid biopsy for translational research grows, customized panels with low sample inputs and high sensitivity become essential requirements for NGS-based assays.

“Reference standard material for circulating tumor DNA is vital for the implementation of liquid biopsy analysis” said Dr. Timothy Harkins, CEO of Swift Biosciences. “Understanding and characterizing any NGS assay for liquid biopsy samples will require well-defined reference reagents. Standards like Seraseq ctDNA reference material allow the community to first understand ctDNA properties, optimize assays and then ultimately use ctDNA in innovative assays to detect and monitor cancer burdens within samples. In turn, this type of work will lay the foundation for transforming future cancer treatments.”

About Swift Biosciences, Inc.
Swift Biosciences is developing innovative and enabling technologies for genomics research. The company’s Accel-NGS® product portfolio brings unique capabilities to improve the efficiency and quality of NGS sample preparation across multiple applications. The Accel-NGS library preparation kits offer high performance sequence coverage metrics, even from challenging samples, and can generate PCR-free libraries for whole genome sequencing from as little as 10 ng of genomic input. The Accel-Amplicon products encompass multiple panels that include a 56G Oncology Panel, a Sample_ID panel, and custom panels across multiple genomes. Swift Biosciences also offers kits for bisulfite-converted DNA for methylation sequencing and a product for single-stranded DNA, ideal for viral and phage metagenomes. For more information, please visit www.swiftbiosci.com and follow Swift Biosciences on Twitter (@SwiftBioSci).

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).