LGC Clinical Diagnostics launches a comprehensive DYPD reference material to advance personalized cancer treatment and pharmacogenomics
Gaithersburg, Maryland, USA – 15 September 2024 – LGC Clinical Diagnostics, a leader in quality solutions for molecular diagnostics, is delighted to announce the launch of the Seraseq® DPYD DNA Mutation Mix. This launch marks LGC Clinical Diagnostics’ entry into the rapidly expanding field of pharmacogenomics, furthering its commitment to personalized medicine. This cutting-edge reference material is designed for developing, validating, and routinely evaluating Next Generation Sequencing (NGS) assays and other molecular assays that detect critical mutations in the DPYD gene.
The DPYD gene encodes the dihydropyrimidine dehydrogenase (DPD) enzyme, crucial for metabolizing fluoropyrimidine-based chemotherapy drugs, such as fluorouracil (Adrucil®), tegafur, and capecitabine (Xeloda®). Mutations in the DPYD gene can impair DPD enzyme activity, leading to severe and life-threatening toxicity in patients undergoing chemotherapy. Identifying DPYD mutations is, therefore, crucial for improving patient safety and enabling personalized treatment plans.
The Seraseq® DPYD DNA Mutation Mix provides an essential tool for clinical laboratories, research institutions, and diagnostic assay developers. It supports consistent and reliable results across platforms and conditions, allowing for the validation of genetic assays and the maintenance of high accuracy standards in detecting DPYD variants.
This highly multiplexed reference material contains 39 carefully selected DPYD variants informed by expert recommendations, clinical guidelines from global authorities such as CPIC, EMA, and DPWG, and insights from public health programs and commercial assay panels. The mutation mix includes non-functional variants affecting fluoropyrimidine drug response. To address the limitations in many existing panels, the product incorporates variants from diverse ethnic groups, making it the first truly pan-ethnic DPYD reference material of its kind.
“We are proud to introduce the Seraseq® DPYD DNA Mutation Mix, filling a critical gap in pharmacogenomics and cancer treatment” said Russell Garlick PhD, Scientific Affairs Lead, at LGC Clinical Diagnostics. “This product exemplifies our commitment to supporting precision medicine and improving patient outcomes by providing high-quality reference materials that enhance the reliability and accuracy of genetic testing.”
For more information about this product and how it can support your laboratory’s testing needs, please visit our website or contact our customer service team.
For more information, please visit the SeraCare website or 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.