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.