Charlotte, NC and Milford, MA, November 10, 2016 - SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, is announcing at the 2016 AMP Annual Meeting in Charlotte a collaboration with UK NEQAS, a leading provider of external quality assessment (EQA) schemes. The UK-based provider plans to incorporate these materials into one of the first widespread global NIPT EQA schemes (in collaboration with two other EQA providers; CEQAS and EMQN), and work together with SeraCare toward the implementation of industry-leading NIPT reference materials.
NIPT is the analysis of cell-free DNA (cfDNA) from maternal blood to screen for common prenatal aneuploidies such as Down syndrome (trisomy 21). As such assay services continue to expand globally, it is extremely critical for laboratory managers to ensure that the clinical diagnostic results from NIPT assays are accurate, timely, and consistent. The use of remnant patient samples as controls is not a viable solution as they are often limited in supply, contain unknown levels of fetal cfDNA, or lack sufficient consistency to be used reliably as reference materials. Hence, laboratories performing such tests need reliable, patient-like reference materials for assay development, validation, daily run QC, and to ensure the accuracy and consistency of test results.
The Seraseq Aneuploidy Reference Material product line is the industry's first full-process reference material for assessing NIPT performance. They are 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 stabilized and blended into a plasma-like matrix under proprietary technology developed at SeraCare.
UK NEQAS has been providing comprehensive global EQA programs since 1969 and now covers over 390 annual schemes. "The objective of our assessments is to ensure that the right result is provided on the right specimen at the right time, and interpreted according to the right reference data, so ultimately the patient receives the highest clinical care," said Sandi Deans, PhD, Director of UK NEQAS for Molecular Genetics. "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. 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."
"As the leading provider of reference materials for NIPT, our goal is to enable clinical laboratories to accurately and confidently assess assay performance. We are very excited to collaborate with UK NEQAS on this first large-scale proficiency scheme for NIPT and help labs around the world compare performance with one another," said Trevor Brown, Vice President of Precision Medicine at SeraCare. "The feedback and insight from leading partners at UK NEQAS will help us to continue to expand our innovative QC portfolio in support of these fast-growing clinical applications for reproductive health with the goal of helping laboratories develop better and more accurate assays with the ability to track their daily performance."
About UK NEQAS
Since 1969 the United Kingdom National External Quality Assessment Service (UK NEQAS) has been providing a comprehensive world-wide service that enables laboratories to fulfill quality goals and facilitate optimal patient care (www.ukneqas.org.uk). UK NEQAS now comprises a network of 390 schemes operating from 26 centres based at major hospitals, research institutions and universities throughout the UK. The services cover qualitative and interpretative investigations in reproductive science, cellular pathology, clinical chemistry, genetics, haematology, immunology and microbiology.
UK NEQAS for Molecular Genetics (www.ukneqas-molgen.org.uk) provides external quality assessment for a range of inherited diseases and acquired disorders currently tested in diagnostic molecular laboratories. The scheme gives objective information and advice to clinical laboratories throughout laboratory molecular medicine on the quality of their analytical and interpretative performance, in order to help them provide accurate and reliable test results and
advice to clinicians, which facilitates optimal patient care. Advances in our understanding of genetic diseases have led to a revolution in testing technologies. UK NEQAS for Molecular Genetics is committed to providing external quality assessment in this rapidly evolving field. UK NEQAS for Molecular Genetics has accreditation to ISO 17043.
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 ensure 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).