NIPT is the analysis of cell-free DNA (cfDNA) from maternal blood to screen for common trisomies, primarily by next-generation sequencing (NGS). 

With higher detection rates than traditional first trimester screening, it is rapidly becoming the preferred screening method and continues to expand globally, especially in average-risk populations.

There is, however, a critical and urgent need for high quality and widely distributed reference materials that mimic authentic cfDNA characteristics and offer patient-like commutability to ensure assay accuracy, consistency, and reliability. 

SeraCare's aneuploidy reference materials are precise mixtures of fetal DNA – derived from trophoblast cells from confirmed trisomies – and normal female DNA, fragmented to a size distribution similar to a natural cfDNA size profile, then stabilized and blended into a plasma-like matrix under proprietary technology developed at SeraCare.

This material can be treated just like a patient sample from the extraction step through data analysis, and can be used to determine analytical performance of NIPT assays down to 1% fetal fraction levels.

Under the terms of the agreement, SeraCare will provide Laboratoire CERBA with Seraseq Aneuploidy Reference Material at specified fetal fraction levels to support validation and daily run performance monitoring of NGS-based trisomy 13, 18, and 21 screening assays across the entire workflow from extraction through sequencing and data analysis.

Laboratoire CERBA is a leading European reference laboratory that offers a broad portfolio of clinical pathology services, and was one of the first labs to offer routine NIPT services in Europe. "

"We are very excited to be working with leading laboratories around the world, such as Laboratoire CERBA, who are focused on delivering the highest quality assay results for their customers," said Trevor Brown, Vice President of Precision Medicine at SeraCare.