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SeraCare to Supply NIPT Reference Materials for UK External Quality Assessment Program

NEW YORK (GenomeWeb) – SeraCare Life Sciences announced yesterday that it has signed an agreement under which its Seraseq aneuploidy reference materials will be incorporated into a non-invasive prenatal testing (NIPT) external quality assessment (EQA) program being developed by the United Kingdom National External Quality Assessment Service (UK NEQAS).

According to SeraCare, the reference materials comprise precise mixtures of fetal DNA derived from trophoblast cells from confirmed trisomies and normal female DNA, fragmented to a size distribution similar to the natural cfDNA size profile, and then stabilized and blended into a plasma-like matrix using a proprietary technology.

"There is a lack of patient-like reference material that can be used by the diverse group of NIPT providers to ensure accuracy, consistency, and reliable peer comparison," Sandi Deans, director of molecular genetics at UK NEQAS, said in a statement. "Through this collaboration with SeraCare, we want to ensure that clinical laboratories have access to robust and relevant reference materials developed with strong underlying technology which can be demonstrated to improve testing through EQA delivery."

SeraCare said that UK NEQAS is developing the NIPT EQA scheme in collaboration with two other British EQA providers — the European Molecular Genetics Quality Network and Cytogenetic External Quality Assessment Service — and that it will work with the groups to implement NIPT reference materials.

Further terms of the agreement were not disclosed.