Spectral Diagnostics, Inc. is a specialty life sciences company focused on the development, manufacturing and marketing of diagnostic reagents, calibrators and quality control products for clinical laboratories and research institutions. The company’s core expertise lies in spectrophotometric and immunoassay technologies, which underpin its portfolio of products designed to ensure accuracy and reliability in biochemical and molecular testing. Spectral Diagnostics’ offerings include proprietary calibrators and controls for chemistry analyzers, immunoassay systems and hematology platforms, along with custom assay development services for emerging biomarkers.
Founded in 1997 and headquartered in Ontario, Canada, Spectral Diagnostics has built a global distribution network that serves laboratory customers across North America, Europe and the Asia-Pacific region. The company’s research and development efforts are concentrated on advancing assay performance, expanding the range of detectable analytes and streamlining workflows in high-throughput testing environments. Spectral Diagnostics collaborates with academic centers and industry partners to translate novel biomarker discoveries into validated diagnostic kits, with a focus on oncology, metabolic disorders and infectious diseases.
In addition to its off-the-shelf reagent lines, Spectral Diagnostics offers contract manufacturing and custom formulation services, enabling pharmaceutical and diagnostic companies to bring new tests to market efficiently. The company maintains ISO 13485 certification for medical device quality management and pursues regulatory clearances including CE marking and FDA 510(k) applications. To support customer training and technical service, Spectral Diagnostics operates regional application labs where laboratory professionals can evaluate products and receive hands-on instruction.
Under the leadership of Chief Executive Officer Dr. Michael A. Burgess and Chief Financial Officer Linda M. Chen, Spectral Diagnostics is executing a strategy to broaden its point-of-care testing capabilities and strengthen its presence in emerging markets. With a seasoned management team and a pipeline of next-generation assays, the company aims to address evolving diagnostic needs and deliver solutions that enhance patient care through improved laboratory efficiency and analytical precision.
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