LGC Clinical Diagnostics has over 35 years of experience as a leading and trusted global manufacturer of Quality Management Tools (QMT) and reagent components. We partner with In Vitro Diagnostics (IVD) and biopharmaceutical developers, clinical research organizations (CROs) and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early-stage research, through expedited product development and onwards into routine clinical use. Laboratories and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics, and clinical genomics rely on LGC’s products to achieve accurate and reliable diagnostic results.
Our combined and ever-growing capabilities mean we are better positioned to support the needs of the clinical diagnostics industry, from early feasibility and research to commercial & laboratory development test (LDT) assay development, installation, validation and ongoing performance monitoring support. LGC Clinical Diagnostics Quality Management and reagent component manufacturing facilities are FDA-registered, and ISO 13485 and ISO 9001-certified.
Our brands include three IVD manufacturers of QMTs and one manufacturer of viral and bacterial antigens and antibodies:
Maine Standards Company Calibration verification materials, validation & qualification panels, calibrators, and OEM PT/EQA samples
SeraCare Quality Controls, Reference Materials, Biological Materials, reagent components
Technopath Clinical Diagnostics Independent Quality Controls & QC Software Solutions
The Native Antigen Company Viral and bacterial antigens/antibodies
Together, our brands serve over 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.