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SeraCare Life, NCI partner to develop controls for cancer assays

Vitro diagnostics manufacturer SeraCare Life Sciences will develop reference materials and positive controls for cancer assays, under a partnership with the National Cancer Institute (NCI).

A cooperative research and development agreement (CRADA) to this effect was signed between SeraCare and NCI.

As per the agreed terms, the partners will investigate the development of methods to mix and accurately quantitate control DNA biosynthetics spiked into a genomic DNA background and cell-free circulating tumor DNA (ctDNA) for next-generation DNA sequencing (NGS) applications.

SeraCare Life Sciences chief science officer Russell Garlick said: "Together with our NCI collaborator, SeraCare’s molecular development and GMP-driven manufacturing capabilities, we believe the research programs under the CRADA have the potential to accelerate the development and widespread use of quality controls to help ensure the correct mutational profiles are reported for patients suffering with advanced stage malignancies.

"This agreement, along with SeraCare’s recent investments to expand laboratory and manufacturing space at our new Molecular Diagnostics Center of Excellence, will help advance our goal of enabling precision medicine."

The newly developed control materials can be used as quality control materials which could help determine an assay’s ability to detect multiple oncogenic mutations.

Additionally, these new materials will be tested to demonstrate that similar results can be obtained between methods, platforms or testing sites.