NEW YORK (GenomeWeb) – SeraCare Life Sciences has announced a collaboration with the US National Institute of Standards and Technology (NIST) to develop circulating tumor DNA (ctDNA) reference standard materials for diagnostics.
Under the terms of the three-year cooperative research and development agreement, SeraCare will provide its Seraseq ctDNA reference material technology to NIST for the development of digital PCR measurement methodologies. NIST will distribute these materials to various laboratories and will compare their results.
The joint effort will advance development of calibrated reference standards for circulating tumor DNA, SeraCare said in a statement.
"The inter-laboratory 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," added Kenneth Cole, a group leader in NIST's Biosystems and Biomaterials Division.
Milford, Massachusetts-based SeraCare offers ctDNA reference materials that can be treated like patient samples and can be used to determine analytical performance of ctDNA assays for allele frequencies as low as 0.1 percent. These materials contain mixtures of DNA fragments carrying varying numbers of somatic driver mutations at specific allele frequencies in a fragmented genomic DNA background from a single individual, which are blended into a synthetic plasma-like substance.
In April, SeraCare signed an agreement to provide Toma Bio Forge with its Seraseq reference material to support development of solid tumor analysis and liquid biopsy tests.