LGC Clinical Diagnostics Launches Seraseq® Carrier Screening DNA Mix Reference Materials
Gaithersburg, Maryland, USA – August 13, 2024 – LGC Clinical Diagnostics is pleased to announce the launch of its Seraseq® Carrier Screening DNA Mix, a new reference material designed to support clinical laboratories in the development, validation, and routine assessment of Next Generation Sequencing (NGS) expanded carrier screening assays. These assays are crucial for identifying inherited variants in genes associated with monogenic diseases, aiding in the risk assessment of genetic disorders.
Carrier screening is an essential tool in genetic testing, particularly for identifying carriers of recessive gene mutations that may be passed on to offspring. Carriers possess one copy of a mutated gene but typically do not show symptoms. If both parents are carriers of the same mutation, there is a 25% chance their child could inherit two mutated copies, leading to the manifestation of the disorder.
Product Features: The Seraseq Carrier Screening DNA Mix includes 54 clinically significant single nucleotide variants (SNVs), deletions, and duplications across 48 genes. These variants are linked to a broad spectrum of monogenic disorders, such as:
- Cystic Fibrosis
- Spinal Muscular Atrophy (SMA)
- α- and β-thalassemia
- Congenital deafness
- Fragile X syndrome
- Sickle cell disease
- Tay-Sachs disease
- Gaucher disease
- Phenylketonuria
- Cardiomyopathy
- Smith-Lemli-Opitz syndrome, and many more.
Technical Specifications: These reference materials are meticulously crafted, with variants embedded in the well-characterized GM24385 genomic background. Each variant is present at clinically relevant allele frequencies, accurately quantitated by digital PCR and further verified by NGS. This ensures reliable performance for assay developers and clinical laboratories.
Benefits:
- Cost Efficiency: A single vial contains a comprehensive mix of 54 variants, reducing the need for multiple reference materials.
- Robust Validation: allows thorough validation of an assay performance to ensure compliance with good laboratory guidelines and other regulations, whist verifying accuracy of the test results.
- Consistency: use of 3rd party controls provides a sustainable source of hard-to-find variants and ensures long shelf life and reproducibility across assays.
- Versatility: Suitable for both routine performance assessment and assay validation over time.
This launch highlights LGC Clinical Diagnostics’ commitment to advancing genetic testing with innovative, high-quality products that support the accuracy and reliability of NGS-based carrier screening assays.
For more information, contact:
Melissa Berenger
Product Manager, LGC Clinical Diagnostics
melissa.berenger@lgcgroup.com
About LGC Clinical Diagnostics
LGC Clinical Diagnostics, part of the LGC Group, has over 30 years of experience as a leading and trusted global IVD quality manufacturer, with 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.
www.lgcclinicaldiagnostics.com
About SeraCare
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.