R&D Agreement for Development of CtDNA Diagnostics

SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers, and the U.S. Department of Commerce's National Institute of Standards and Technology (NIST) have signed a three-year Cooperative Research and Development Agreement (CRADA) to advance the development of circulating tumour DNA (ctDNA) diagnostic assay reference standard materials. Detection of cell-free circulating tumour DNA is a promising method (sometimes called 'liquid biopsy') with the potential to diagnose, profile, and monitor cancer, and there is an acute need for standards to compare the detection limits of diagnostic assay development.

SeraCare's ctDNA reference materials are mixtures of size-appropriate fragments of DNA containing highly multiplexed numbers of somatic 'driver' mutations, produced at very specific allele frequencies in a defined, fragmented genomic DNA background from a single-individual; then stabilized and blended into a synthetic plasma-like matrix under proprietary technology developed at SeraCare. This material can be treated just like a patient sample run through the full extraction and analysis process, and can be used to determine analytical performance of a ctDNA molecular assay down to as low as 0.1% allele frequency (a single mutant molecule in 1,000 normal ones).

Under the terms of the agreement, SeraCare will provide their Seraseq™ ctDNA Reference Material technology to NIST for development of digital PCR measurement methodologies, and NIST will facilitate a wider distribution of these materials to anonymized laboratories for inter-laboratory comparisons. The joint efforts are meant to hasten the development of calibrated reference standards for circulating tumour DNA – critical for expanding the use of these technologies into the translational research and diagnostic labs.

"SeraCare and NIST make a natural fit, given NIST's measurement expertise and commitment to bridge the worlds of translational research and clinical diagnostics," said Dr. Russell Garlick, CSO of SeraCare Life Sciences. "NIST can facilitate the rapid adoption of calibrated and highly functional molecular standards in the rapidly evolving field of circulating tumour DNA assay development."

"The interlaboratory comparisons made possible by this partnership will speed NIST's efforts to overcome measurement challenges and advance cancer-detection technology broadly for the biomedical community," said Kenneth Cole, a group leader in NIST's Biosystems and Biomaterials Division. "Studies have shown that circulating tumour DNA can be detected in many cancers and it can be used to monitor therapeutic progress."