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In response to the global health emergency caused by the recent outbreak of coronavirus strain 2019-nCoV, LGC’s SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostic manufacturers and clinical laboratories, is announcing the development of molecular reference materials for coronavirus utilizing their proprietary AccuPlex™ recombinant technology.
The control material is being produced in collaboration with several diagnostic manufacturers to support development, evaluation, and validation of molecular test methods directed to 2019-nCoV.
AccuPlex reference materials, while mimicking wild-type pathogenic viruses, are safe, non-infectious, and replication-deficient. They serve as true, full-process, quality control solutions that challenge the entire diagnostic workflow, making them a valuable alternative to infectious materials.
Greg Ballish, Senior Vice President of Commercial, stated: “SeraCare Life Sciences has successfully employed AccuPlex technology in response to other recent infectious disease outbreaks, including Zika and Ebola virus. We are now working with our partners in the diagnostic industry to expedite production of similar quality control solutions to ensure appropriate validation of newly developed 2019-nCoV assays, consistency during patient testing events, and in support of proper virus identification and containment efforts. We will continue to provide updates on its development and support activities related to the coronavirus health emergency.”
LGC’s Biosearch Technologies team, the inventor of specific chemistries such as Black Hole and Blackberry Quenchers, and other critical dyes and components used in diagnostic kits, is also expediting availability of mission-critical oligo chemistries, controls and components that deliver 2019-nCov coronavirus detection kits at scale.
About LGC’s Clinical Diagnostics unit
LGC’s Clinical Diagnostic Business Unit exists within the LGC’s Standards Division and is comprised of two operating entities - SeraCare Life Sciences and Maine Standards Company. We are in vitro diagnostic (IVD) manufacturers of clinical diagnostic quality solutions to the extended life science industry.
Our 200+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland and support diagnostic professionals in laboratories across the globe. We partner with IVD developers, pharmaceutical, CRO and academic institutions to share our expertise and resources in clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics.
We are committed to improving patient healthcare by offering products and services that support accurate and reliable diagnostic results.
LGC is an international leader in the extended life sciences sector, including human healthcare, agri-food & the environment. LGC provides a comprehensive range of reference materials, proficiency testing schemes, and genomics reagents, as well as research and measurement services. Its scientific tools and solutions enable organisations to advance research, develop new products and form an essential part of their quality and compliance procedures.
LGC’s 3,150 employees include internationally recognized scientists who are experts in their field. Headquartered in London, it operates out of 19 countries worldwide and is extensively accredited to quality standards such as GMP, GLP, ISO 13485, ISO 17034, ISO 17043, ISO/IEC 17025 and ISO 9001.
LGC has been home to the UK Government Chemist for more than 100 years and is the UK National Measurement Laboratory and Designated Institute for chemical and bio measurement. LGC has been privately-owned since 1996 and has diversified through internal investment and acquisition to be an international leader in its chosen markets. LGC is now owned by funds affiliated with KKR.