Milford, MA, USA, 1 August 2022 - LGC Clinical Diagnostics, a leading supplier and partner to global in vitro diagnostics manufacturers and clinical laboratories, announced today the extension of its exclusive collaboration with Stanford Medicine's Department of Obstetrics & Gynecology - Maternal Fetal Medicine Division and Metabolic Health Center.
Under the terms of the agreement, physician-scientists at Stanford Medicine will continue to provide LGC Clinical Diagnostics with clinical guidance in recruiting and selecting rare patient donors’ blood samples whose pregnancy has been identified with a genetic abnormality. These cases allow LGC to manufacture reference materials for cell-free DNA (cfDNA) screening, also known as Non-Invasive Prenatal Screening/Testing (NIPS/NIPT), to enable highly accurate genetic testing.
Thanks to its innovative and patent-pending technology, LGC Clinical Diagnostics' SeraCare brand supplies researchers and clinicians with patient-derived and patient-like reference materials, helping them develop, validate, and implement assays with high confidence. Details of the unique methodology have been previously published (Bianco, Katherine et al. 2021). Unlike cell-line derived reference materials, the Seraseq® line of NIPT full-process reference materials preserve the maternal and fetal cfDNA content, size distribution and unique characteristics of the DNA, allowing LGC Clinical Diagnostics to manufacture the best alternative to hard-to-source clinical samples; suitable for the vast majority of NIPT assays including SNP-based ones and those which bioinformatics pipeline analyzes the differences in maternal and fetal cfDNA representations.
The exclusive contract has also been extended to include the analysis of phenotypic-genotypic correlations and metabolic profiling of some common maternal/fetal cardiac defects known to be related to monogenic disorders. Metabolic profiling of different disease states, including maternal metabolic syndromes, placental abnormalities leading to adverse prenatal outcomes, and congenital heart defects will be the focus of this study. Using the samples collected and analyzed, the LGC team plans to develop reference materials and disease state panels to help assay development, validation, and quality control.
“Our collaboration with Stanford Medicine has been key to designing and developing quality control standards for fetal maternal medicine and NIPT. This year, we hope to make further contributions advancing biochemical profiling using mass spec-based metabolomics to help identify biomarkers for early indications of maternal fetal disorders that emerge late in pregnancy,” said Dr. Russell Garlick, Chief Scientific Officer, LGC Clinical Diagnostics.
Since June 2022, customers have been able to order Seraseq Sex Chromosome Aneuploidy (SCA) reference materials in addition to materials for other common aneuploidies and a microdeletion. SCAs are genetic conditions caused by abnormalities in the number of X and Y sex chromosomes, which include 45,X (Turner syndrome), 47,XXY (Klinefelter syndrome), and 47,XYY (Jacobs syndrome). With a combined incidence of ~1 in 400 live births, SCAs occur more frequently than trisomy 21 (1:700) and can be screened by the majority of commercially NIPT assays.
For more information, please visit the SeraCare website or contact:
Product Manager, Genomic Health
LGC Clinical Diagnostics
About LGC Clinical Diagnostics
LGC Clinical Diagnostics, part of the LGC Group, has more than 30 years of experience as a leading and trusted global IVD quality manufacturer, with particular expertise in quality measurement tools (QMT) and reagents. Focused on five key areas – clinical biochemistry and immunoassay, serology, molecular diagnostics, clinical genomics, and reagents – it has around 450 employees across its three FDA-registered and ISO 13485-certified facilities in the USA, England and Ireland, and an ISO 9001-certified facility in England.
LGC Clinical Diagnostics partners with IVD and biopharmaceutical developers, CROs and academic institutions covering the entire diagnostic pipeline, from concept and early-stage research to accelerated product development and, ultimately, routine clinical use. It develops and manufactures a comprehensive portfolio of premium catalogue and custom-developed diagnostic quality solutions and component materials for the IVD and extended life sciences industry through its four brands, Maine Standards Company, SeraCare, The Native Antigen Company and Technopath Clinical Diagnostics. Together, they serve 7,500+ customers in over 120 countries, providing products for more than 20 clinical application areas, including infectious diseases, NIPT, diabetes, cardiac disease and oncology.
About SeraCare – seracare.com
SeraCare, founded in 1984, is a leading partner to global in vitro diagnostics manufacturers and clinical laboratories. Part of LGC since 2018, it manufactures and supplies quality control materials for infectious disease testing through its ACCURUN® reagents, as well the Seraseq® range of products for the clinical next generation sequencing market in the fields of oncology, NIPT and inherited disease testing. A broad selection of highly multiplexed, patient-like reference materials with clinically-relevant DNA and RNA variants is available, manufactured in cGMP-compliant, ISO 13485-certified facilities.