C2N Diagnostics, a global leader in Alzheimer’s diagnostics with its Precivity blood tests, plans to develop a fully automated and standardized high-resolution LC-MS platform. This technology will allow local clinical labs worldwide to utilize the precise innovation behind C2N’s clinical and research biomarkers.
C2N Diagnostics has secured up to $7.025 million from the Alzheimer’s Drug Discovery Foundation’s (ADDF) Diagnostics Accelerator initiative, which focuses on developing advanced biomarkers and diagnostic technologies for early Alzheimer’s detection. C2N plans to revolutionize Alzheimer’s diagnosis with its high-performance LC-MS solution, addressing the unmet need for precise, early detection. The company will develop an end-to-end platform, including instruments and diagnostic kits, enabling research and clinical labs worldwide to detect fluid biomarkers linked to Alzheimer’s.
The platform will support multiple assays tracking both amyloid and tau pathologies and will allow for the future inclusion of C2N assays targeting other neuropathological markers. C2N’s decentralized testing approach, developed in compliance with regulatory standards, aims to meet the growing global demand for early and accurate Alzheimer’s detection.
Recent research published in The Journal of the American Medical Association highlighted the effectiveness of C2N’s PrecivityAD2™ test, which demonstrated over 90% accuracy compared to cerebrospinal fluid (CSF) and amyloid PET analyses, thanks to the company’s LC-MS platform.
Dr. Howard Fillit, Co-Founder and Chief Science Officer of ADDF, emphasized the importance of C2N’s Precivity blood tests in providing accessible and accurate diagnostic tools for Alzheimer’s, while Niranjan Bose of Gates Ventures praised C2N’s role in advancing early diagnosis and clinical trial enrollment.
C2N CEO Dr. Joel Braunstein expressed gratitude for the Diagnostics Accelerator’s support, stating that early detection is crucial for altering the course of Alzheimer’s through early treatment and prevention. The company aims to scale up its LC-MS clinical analyzer to meet the global demand, with many labs already interested in adopting the Precivity™ tests.
The global scalability project will run alongside ongoing testing at C2N’s CLIA-certified, CAP-accredited lab in St. Louis, which currently performs Precivity tests as Laboratory Development Tests (LDT). This initiative coincides with World Alzheimer’s Month and follows a multi-year partnership with Unilabs to expand access to C2N’s blood tests across Europe, Peru, Saudi Arabia, and the UAE, as well as a non-exclusive agreement with Mayo Clinic Laboratories.
C2N, which received Breakthrough Device Designation from the FDA in 2018, is recognized as a preferred diagnostics provider by leading biopharmaceutical companies worldwide. Precivity tests can be ordered by authorized healthcare providers, with patients in the U.S. having access to over 700 service centers and 13,000 mobile phlebotomists.
About C2N Diagnostics, LLC:
C2N Diagnostics specializes in brain health diagnostics, offering high-resolution mass spectrometry-based biomarker services and products for clinical decision-making, clinical trials, and research. Their assays have been used in over 150 Alzheimer’s and other research studies globally. C2N partners with leading labs worldwide to expand access to Precivity™ testing and collaborates with major pharmaceutical and biotech companies, academic institutions, and non-profits.
