Milford, Massachusetts, July 28, 2015 – SeraCare Life Sciences, a leading partner to global in vitro diagnostics manufacturers, announced today at the American Association of Clinical Chemistry (AACC) meeting that it has signed a licensing agreement with the University of California, San Francisco (UCSF) for the use of Trisomy 21 (T21), Trisomy 18 (T18) and Trisomy 13 (T13) trophoblast cell line material as a component for creating “patient-like” reference materials for Non-Invasive Prenatal Testing (NIPT) of chromosomal abnormalities.
Additionally, SeraCare Life Sciences also announced the launch today of its Early Access Program for the first ever circulating cell-free fetal DNA (cfDNA) T21, T18 and T13 aneuploidy reference materials, developed using the UCSF cell technology. SeraCare will seek early access partnerships with collaborators to both evaluate and refine this product in order to meet their specific requirements.
The detection of circulating cell-free fetal DNA (cfDNA) in maternal blood by next-generation sequencing is rapidly becoming the preferred method to screen for chromosomal abnormalities. As the market for these screening tests continues to grow and more labs begin offering these services, there is a need for reliable reference materials to ensure the accuracy of results. This is especially critical as labs scale up their operation and need to train, validate, optimize and monitor ongoing performance of their next-generation sequencing or microarray assays.
“We are excited to see that research innovations conducted in our lab at UCSF will be utilized for these advancements and can offer benefit to patients, SeraCare and UCSF. We hope that these cell lines can assist in the development of the first aneuploidy reference material,” say Susan J. Fisher, Ph.D., Professor, and Katherine Bianco, M.D., former Assistant Professor, in the Division of Maternal-Fetal Medicine at UCSF. Under the terms of the agreement, SeraCare Life Sciences will pay UCSF an upfront payment as well as additional payments based on the achievement of particular development and commercial milestones.
These are additional examples of SeraCare’s continuing investment in the area of precision medicine, consistent with the company’s recent announcements regarding an expansion of its research facility in Maryland and the launch of Seraseq™ Solid Tumor Mutation Mix—I (AF20); a biosynthetic reference material designed to evaluate the performance of NGS-based tumor profiling assays.
“The licensing agreement with UCSF and launch of our Early Access Program for cfDNA aneuploidy reference materials is one more step in our journey as we work hard to develop innovative, high value products for these new and advanced diagnostic platforms. By being able to partner and license key technologies from leading institutions, such as UCSF, we are able to accelerate our product development programs, helping to bring the latest innovations to market more quickly,” says Charlie Mamrak, CEO, SeraCare Life Sciences.
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 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).