LGC Clinical Diagnostics announces the launch of the Seraseq® DPYD DNA Mutation Mix, which is a 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.
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.
LGC Clinical Diagnostics, announces the release of its Seraseq® BRCA1/2 Large Genomic Rearrangements Reference Materials, designed to meet the needs of clinical laboratories testing for BRCA1/2 gene variants at both somatic and germline levels.
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.
LGC SeraCare is pleased to announce that the AccuPlex™ SARS-CoV-2, Flu A/B and RSV Reference Material Kit is now CE marked for in vitro diagnostic use (CE-IVD). With this change in regulatory status, the new product name is AccuPlex SARS-CoV-2, Flu A/B and RSV Molecular Controls Kit. Bearing the CE mark and IVD symbol signifies that the AccuPlex SARS-CoV-2, Flu A/B and RSV Molecular Controls Kit meets extensive design control requirements. The CE-IVD version of the product also includes expanded RSV target regions offering increased compatibility with commercially available assays.
LGC SeraCare has released AccuPlex™ SARS-CoV-2 Variant Panel 2, further expanding its line of SARS-CoV-2 molecular quality solutions to include material for Delta variant detection and analysis. AccuPlex SARS-CoV-2 Variant Panels offer full SARS-CoV-2 genome coverage with a focus on S-gene mutations in prominent variants of concern, with Variant Panel 2 featuring Kappa, Delta and Delta Plus. Wuhan wild type and an RNase P negative control are also included in the kit. This solution is compatible with multiple applications, including performance confirmation for existing SARS-CoV-2 molecular assays as well as SARS-CoV-2 variant genotyping or NGS assays.
LGC SeraCare has expanded its line of SARS-CoV-2 molecular quality solutions to include AccuPlex™ SARS-CoV-2 Variant Panel 1. The kit contains full SARS-CoV-2 genomic RNA with a focus on S-gene mutations in three prominent variants of concern (UK variant B.1.1.7, South Africa variant B.1.351, and Brazil variant P.1) with vials for each variant as well as wild type control and human RNase P negative control vials. This solution is compatible with multiple applications, including performance confirmation for existing SARS-CoV-2 molecular assays as well as SARS-CoV-2 variant genotyping or NGS assays.
LGC SeraCare has released ACCURUN® SARS-CoV-2 Antigen Reference Material Kit, a new quality measurement tool to support SARS-CoV-2 antigen testing. It is formulated for use with test methods that detect the nucleocapsid (NP) protein of SARS-CoV-2 virus – the target for the majority of the SARS-CoV-2 antigen assays currently on the market.
LGC SeraCare has expanded its innovative portfolio of SARS-CoV-2 quality solutions with the release of AccuPlex™ SARS-CoV-2 in Synthetic Oral Fluid reference material. The product is designed to support development and testing efforts around novel saliva-based SARS-CoV-2 diagnostics. It serves as an ideal research tool for assay developers as well as a complete quality solution for clinical laboratories employing such tests.
LGC SeraCare is pleased to announce that the ACCURUN® Anti-SARS-CoV-2 Reference Material Kit is now CE marked for in vitro diagnostic use (CE-IVD). With this change in regulatory status, the new product name is ACCURUN Anti-SARS-CoV-2 Controls Kit. Bearing the CE mark and IVD symbol signifies that the ACCURUN Anti-SARS-CoV-2 Controls Kit meets extensive design control requirements.
LGC SeraCare has expanded the line of SARS-CoV-2 quality solutions to include products designed for use with multiplexed molecular assays that can detect SARS-CoV-2, influenza A/B and respiratory syncytial virus (RSV).
LGC SeraCare is pleased to announce that the AccuPlex™ SARS-CoV-2 Reference Material Kit v2 is now CE marked for in vitro diagnostic use (CE-IVD). With this change in regulatory status, the new product name is AccuPlex SARS-CoV-2 Molecular Controls Kit. Bearing the CE mark and IVD symbol signifies that the AccuPlex SARS-CoV-2 Molecular Controls Kit meets extensive design control requirements.
LGC SeraCare continues to innovate its portfolio of products supporting SARS-CoV-2 diagnostics. Initially designed to target the published CDC and WHO consensus sequences, the new AccuPlex™ SARS-CoV-2 Verification Panel and Reference Material Kit are now available with full SARS-CoV-2 viral genome coverage. This expansion allows for compatibility with any SARS-CoV-2 assay target, while maintaining the safety features and performance monitoring advantages of AccuPlex technology.
LGC, the UK based global leader in the life sciences sector has acquired the business of Oxford-based The Native Antigen Company (“NAC”), one of the world’s leading suppliers of high-quality infectious disease antigens and antibodies.
LGC SeraCare has released the AccuSet™ SARS-CoV-2 Performance Panel, intended for use by clinical laboratories and diagnostic manufacturers alike, to evaluate SARS-CoV-2 antibody assays.
LGC SeraCare has released ACCURUN® Anti-SARS-CoV-2 Reference Materials to address the critical need for clinical laboratories to be able to report antibody testing results with confidence, in response to the ongoing COVID-19 pandemic. The ACCURUN kit is designed to support assay installation as well as to monitor day-to-day assay performance, as required by CLIA, CAP, ISO-15189 and many other regulatory or accrediting bodies, providing a complete quality solution for SARS-CoV-2 antibody testing.
In response to the critical need for accurate testing to combat the COVID-19 pandemic, LGC SeraCare continues to innovate and expand their novel AccuPlex™ SARS-CoV-2 Quality Solutions in support of improved diagnostic assay development and testing.
With the rapid global spread of the SARS-CoV-2 virus and the urgent need for reliable diagnostic solutions, LGC’s SeraCare Life Sciences is expanding production of their novel COVID-19 reference materials to include high titer stocks that serve as a valuable tool for diagnostic manufacturers.
SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, announced today their successful selection as a technology partner in support of the first ever tumor mutational burden (TMB) external quality assessment (EQA) program being developed by the International Quality Network for Pathology (IQN Path).
Today, LGC announced the acquisition of SeraCare Life Sciences, Inc., a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories.
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