Immco Diagnostics is a Buffalo-area diagnostic laboratory specializing in autoimmune testing of serology and biopsy specimens, as well as preeclampsia risk testing. Co-founded by periodontists, it has more than 40 years of experience in oral and maxillofacial pathology biopsy services and developed novel biomarkers for its Sjögren’s diagnostic testing.
GLP-compliant environment
Compliance program
CLIA
GLP
Quality certification
KSL Biomedical, IncFounded in 2017, KSL Biomedical develops and manufactures diagnostic tests while providing contract research, clinical, quality, and regulatory services for medical-device and in-vitro diagnostic companies. Based in Buffalo, New York, the company combines its own assay development and New York State manufacturing with integrated clinical laboratories in the United States and Canada. Its team includes specialists who have taken more than 50 assays and medical devices through validation and FDA 510(k) clearance.CHEEKTOWAGA, NY
SeraCareSince the early 1980s, SeraCare has supported the diagnostic testing industry with biological materials that help laboratories and assay developers establish confidence in their results. The Milford-based company is known for patient-like reference materials used in emerging clinical genomics applications, while its ISO 13485-certified, cGMP-compliant facilities provide traceability from sourcing through delivery.IJAMSVILLE, MD
Salimetrics, LLCBorn from Douglas A. Granger’s Penn State lab, Salimetrics has made salivary bioscience tools and testing services since 1998, helping researchers turn saliva and dried blood spots into reliable biomarker data. Its work spans validated assay kits, participant collection systems and CoreLab+ analysis, with methods used in more than 10,000 studies. The company also operates FDA-registered, ISO 13485:2016-certified facilities and a CLIA-certified laboratory for research and diagnostic applications.325413STATE COLLEGE, PA
Meso Scale Diagnostics, LLCRockville-based Meso Scale Diagnostics develops and manufactures immunoassay instruments, assay kits, reagents, and related services for measuring biomarkers in biomedical research and pharmaceutical development. Its S-PLEX platform extends that work to femtogram-per-milliliter sensitivity, enabling researchers to quantify very low-abundance proteins in biological samples. The company’s quality systems have been certified to ISO 9001:2015 and ISO 13485:2016, with the latter covering in-vitro diagnostic product design and development.ROCKVILLE, MD