LGC SeraCare: Enabling the Promise of Precision Medicine
SeraCare Life Sciences, now a cornerstone of the LGC Clinical Diagnostics division, is a leading American manufacturer and supplier of critical quality control materials, reference standards, and biological materials for the global in-vitro diagnostics (IVD) industry. With primary facilities in Milford, Massachusetts and Gaithersburg, Maryland, USA, the company has built a decades-long reputation for providing the essential tools that clinical laboratories and diagnostic assay developers use to ensure the accuracy, reliability, and safety of patient test results. Since its acquisition by LGC in 2018, the entity known as LGC SeraCare has expanded its role as an indispensable partner in advancing precision medicine, from traditional infectious disease serology to the cutting edge of clinical genomics and oncology.
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Core Mission: Ensuring Confidence in Diagnostic Results
The fundamental mission of LGC SeraCare is to remove doubt and add confidence to the entire diagnostic testing process. In an increasingly complex and high-stakes medical environment, laboratories and IVD manufacturers face immense pressure to produce accurate results. An incorrect result can have profound consequences for patient care. LGC SeraCare addresses this challenge by providing highly characterized, patient-like materials that mimic real clinical samples. These materials are used to develop, validate, and routinely monitor the performance of diagnostic assays, ensuring they function correctly day after day. The company's products serve as the "gold standard" controls that help labs meet stringent regulatory requirements and deliver results that clinicians and patients can trust.
Products and Services Offered
LGC SeraCare's offerings are extensive and can be categorized into several key areas, each supporting a different aspect of the diagnostics workflow.
1. Infectious Disease Quality Controls and Reference Materials:
This is a foundational area for the company, providing controls for both molecular and serological testing of infectious diseases.
* ACCURUN? Controls: This flagship brand consists of a comprehensive line of independent, third-party quality controls for serology testing. ACCURUN products are designed to be weakly reactive to challenge an assay at or near the clinical cutoff point, providing a much more rigorous assessment of performance than high-positive controls. They are used worldwide to monitor tests for HIV, hepatitis (HBV, HCV), CMV, EBV, syphilis, SARS-CoV-2, and many other pathogens.
* AccuPlex? Recombinant Virus Technology: For molecular assays (e.g., PCR), AccuPlex provides a safe, non-infectious solution. This technology uses recombinant viral particles that contain the relevant genetic sequences of a pathogen. Because they are constructed as full viral particles, they serve as a full-process control, validating the entire workflow from nucleic acid extraction through amplification and detection. This is a critical tool for labs running tests for HIV, Zika, Ebola, and other high-risk pathogens.
2. Clinical Genomics and NGS Reference Standards:
As medicine has shifted towards genomics, LGC SeraCare has become a leader in providing quality control tools for Next-Generation Sequencing (NGS) and digital PCR (dPCR) assays.
* Seraseq? Reference Materials: The Seraseq product line is arguably the company's most innovative offering, specifically designed for the complexities of NGS. These are highly multiplexed, biosynthetic standards that contain dozens to hundreds of clinically relevant genetic variants (SNVs, indels, fusions, CNVs) in a single sample.
* Oncology: Seraseq offers a vast portfolio for cancer testing, including reference standards for solid tumor profiling, liquid biopsy (circulating tumor DNA, or ctDNA), and hematological malignancies. These materials are available in various formats, including purified DNA, synthetic plasma, and Formalin-Fixed, Paraffin-Embedded (FFPE) cell lines that mimic real tumor tissue biopsies.
* Reproductive Health: The company provides critical reference materials for Non-Invasive Prenatal Testing (NIPT) and Pre-implantation Genetic Testing (PGT-A), allowing labs to validate and monitor assays that detect aneuploidies and other fetal genetic abnormalities.
* Inherited Disease: Reference standards are available to help labs accurately detect germline mutations associated with hereditary diseases.
* iQ? NGS QC Management Software: To complement its physical standards, SeraCare developed software that allows labs to easily monitor and ensure the optimal performance of their NGS assays and maintain compliance with regulatory guidelines.
3. Biological Materials and Custom Services:
Beyond off-the-shelf products, LGC SeraCare serves as a key partner for the IVD manufacturing industry by providing foundational materials and custom solutions.
* Bulk Plasma and Serum: The company is a world leader in processing and supplying bulk human plasma and serum products, both non-infectious and infectious, which are used as raw materials in the manufacturing of new diagnostic kits and controls.
* Custom Solutions: LGC SeraCare leverages its scientific expertise to provide bespoke services. This includes creating custom controls and panels for molecular and serology tests, developing unique NGS reference materials tailored to a client's specific assay, and managing prospective collections of rare patient samples for research and development. This allows assay developers to accelerate their product development with reliable, well-characterized materials.
* Immunoassay Reagents: Through past acquisitions (like KPL), the company continues to provide a portfolio of antibodies, conjugates, and other reagents essential for building immunoassays.
