August 2022

LGC Clinical Diagnostics extend collaboration with Stanford Medicine supporting global genetic and metabolomic diagnostic testing

LGC Clinical Diagnostics, a leading supplier and partner to global in vitro diagnostics manufacturers and clinical laboratories, announced today the extension of our exclusive collaboration with Stanford Medicine's Department of Obstetrics & Gynecology - Maternal Fetal Medicine Division and Metabolic Health Center.

Under the agreement, physician-scientists at Stanford Medicine will continue to provide LGC 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.

“Our collaboration with Stanford 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.

Thanks to its innovative and patent-pending technology, LGC’s 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 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 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.

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.

Visit the SeraCare website to find out more.