MILFORD, Mass., Sept. 22, 2016 /PRNewswire/ -- SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, has signed an agreement with Laboratoire CERBA, a leading European reference laboratory specializing in clinical pathology, to provide custom Seraseq™ Aneuploidy Reference Materials for use with Laboratoire CERBA's non-invasive prenatal testing (NIPT) assay.
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. "With increased focus on quality, both internally in our organization and from regulatory agencies, it is extremely important to have a robust, patient-like reference material that can be used in a manner identical to patient samples across the entire workflow," said Jean-Marc Costa, Medical Director at Laboratoire CERBA. "Seraseq Aneuploidy Reference Materials offer a consistent supply of confirmed trisomies at precise fetal fractions that allows us to confidently monitor daily assay performance, and report accurate results to our clinicians and patients. In addition, multiplexing all three trisomies into a single reference sample instead of three separate samples allows us to save valuable sequencing costs and resources."
"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. "We are pleased our innovative, full-process Seraseq Aneuploidy Reference Materials can provide the assurance in the results that Laboratoire CERBA requires, while also enabling them to monitor long-term performance that is simply not possible using remnant specimens. We look forward to bringing even more critically important genomics tools to clinical laboratories in the coming months."
About Laboratoire CERBA
Laboratoire CERBA is a leading European specialized laboratory based in France and is ISO 15189 accredited. Since its inception in 1967, it has offered private laboratories and public hospitals in more than 35 countries a broad range of specialty testing services, such as molecular biology testing, oncology testing, allergy testing, hormonology testing, infectious disease testing, and diagnostic genetic testing, and has developed broadly recognized expertise in innovation of new tests. Laboratoire CERBA is the first clinical pathology laboratory in Europe performing, in its entirety, cell‐free DNA screening for trisomy 13, 18, and 21 on its specialized clinical pathology platform. Laboratoire CERBA has been highly committed to prenatal diagnosis for the past several years, starting with the implementation of the risk assessment calculation for trisomy 21 using maternal serum markers in 1991; to the implementation of the risk assessment calculation for trisomy 21 using maternal serum markers at the 1st trimester of pregnancy in 2007; and non-invasive prenatal testing assay based on a technology transfer from Sequenom in 2014. Laboratoire Cerba is the founding member of Cerba HealthCare Group. For more information, please visit www.lab-cerba.com.
About SeraCare Life Sciences Inc.
SeraCare enables the promise of precision medicine by advancing the understanding of disease and providing assurance of the diagnostic result. Our innovative tools and technologies not only provide assurance of the safe, effective, and accurate performance of diagnostic assays, but also establish a framework for regulating, compiling, and interpreting data from precision diagnostics. Our portfolio includes a broad range of products such as quality control technologies, disease-state specimens and tissues for research and development, processed biological materials, and immunoassay reagents. For more information, please visit www.seracare.com and follow SeraCare on Twitter (@SeraCare).
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SOURCE SeraCare Life Sciences