Milford, Massachusetts, October 12, 2016 - SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, today announced it is partnering with AAB Proficiency Testing Service (AAB) for the development and use of preimplantation genetic screening (PGS) reference materials. The Houston-based proficiency test provider plans to incorporate these materials into their upcoming PGS proficiency scheme.
PGS is a screening technique to evaluate cells from in vitro fertilization (IVF) embryos for the presence of chromosomal aneuploidies such as trisomy 21, trisomy 18, or trisomy 13. This is increasingly being performed by next-generation sequencing (NGS) and there is a critical and urgent need for reliable reference materials to expedite new test development as well as enable routine monitoring of PGS assay performance.
SeraCare's Seraseq™ PGS Reference Materials consist of precisely quantitated fetal DNA derived from trophoblast cells from either confirmed trisomies or normal pregnancies. These materials can easily be customized to a desired concentration (as low as a few picograms) depending on the PGS assay requirement.
As the IVF market continues to expand globally, AAB’s proficiency testing programs require precise and reliable source materials to ensure the accuracy of the growing number of PGS assays deployed worldwide. AAB is one of the nation’s largest full-service proficiency testing providers, and the leading provider of IVF programs in the country. “As a proficiency test provider, we play an important and independent role in ensuring the accuracy and ongoing consistency of assay performance. It is important that we have a robust, reliable, and consistent supply of reference materials that mimic biochemical composition seen in actual clinical samples in a PGS lab,” said Eric Vanderslice, Ph.D., Vice President and Technical Director at AAB. “Seraseq PGS reference materials offer a consistent and precise supply of trisomy and euploid material that allows us to confidently evaluate assay performance, with the ultimate goal to ensure accurate results to clinicians and IVF patients.”
“SeraCare is already the leading provider of reference materials for non-invasive prenatal testing (NIPT) assays with our Seraseq Trisomy Reference Materials and we are very excited to launch our first product for PGS through this partnership with AAB,” said Trevor Brown, Vice President of Precision Medicine at SeraCare. “We will continue to invest and grow our innovative QC portfolio in support of these fast growing clinical applications for reproductive health with the goal of helping labs develop better and more accurate assays with the ability to track their daily performance.”
AAB Proficiency Testing Service programs have been serving laboratorians for more than 65 years. Our programs are approved by CMS, COLA, JCAHO, A2LA, NY State and accepted by the CAP. Since 1949, AAB Proficiency Testing Service has made comprehensive external quality control programs available to every individual and clinical laboratory wishing to participate. These programs are updated continuously and meet the needs of evolving techniques and concepts in the 21st Century Laboratory.
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).