C2N Diagnostics develops the Precivity portfolio of blood tests and high-resolution LC‑MS/MS biomarker services to aid diagnosis and management of Alzheimer’s disease. Its Precivity tests detect amyloid and tau biomarkers and have been used in over 150 research studies, with more than 30,000 Precivity-related biomarker measures reported. C2N operates a CLIA‑certified, CAP‑accredited laboratory in St. Louis and provides testing as laboratory-developed tests (LDTs), with access via a U.S. network of over 700 patient service centers and 13,000 mobile phlebotomists. The company plans to build a fully automated, standardized, high-resolution LC‑MS clinical analyzer and accompanying diagnostic kits to enable decentralized, local deployment of its assays worldwide. The global scalability project will accommodate multiple assays tracking amyloid and tau pathology and provide a framework to add future neuropathology assays. C2N has established partnerships to expand access to Precivity testing, including a multi-year exclusive agreement with Unilabs for Europe and a non-exclusive agreement with Mayo Clinic Laboratories. The company received an investment of up to $7.025 million from the Alzheimer’s Drug Discovery Foundation’s Diagnostics Accelerator to support the LC‑MS platform effort. C2N Diagnostics develops and provides high-resolution mass spectrometry-based biomarker services and the Precivity™ blood tests intended for use in patients with cognitive impairment. Its Precivity tests are designed to help healthcare providers determine Alzheimer’s disease pathology and aid medical management and treatment decisions. C2N assays have been used in over 150 Alzheimer’s disease and other research studies worldwide, and over 15,000 Precivity-related biomarker measures have been reported in peer-reviewed publications. The company collaborates with pharmaceutical and biotech companies, leading academic institutions, the National Institute on Aging, the Alzheimer’s Association, and other non-profits and consortiums to support clinical trials and research. With Eisai’s investment, C2N plans to scale up and expand the availability, accessibility, and use of its high-performance blood biomarker tests for early diagnosis of Alzheimer’s disease in the U.S. The company also acknowledges support from the National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, BrightFocus Foundation, and Alzheimer’s Association. C2N Diagnostics develops and commercializes blood-based biomarkers for Alzheimer’s disease, including the PrecivityAD® test and the next-generation PrecivityAD2™. The company uses high-resolution mass spectrometry to provide laboratory services and products that support clinical decision-making, clinical trials, and research into neurodegeneration. C2N plans to use new capital to advance PrecivityAD2™, run additional clinical studies to build real-world evidence, and expand global market access and medical education. The company will also invest in biomarker pipeline development, infrastructure growth, and workflow efficiencies to prepare for higher testing volumes and commercial demand. C2N recently marked the two-year anniversary of the PrecivityAD® launch and says the test is the first widely accessible blood test to assist healthcare providers with Alzheimer’s diagnosis. The company acknowledges support from funders including the National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, BrightFocus Foundation, and the Alzheimer’s Association. C2N Diagnostics is commercializing the APTUS™ platform, a panel of blood tests to enable early detection and monitoring of neurodegenerative disorders. Its lead APTUS-Aβ™ test combines mass spectrometry quantification of plasma Aβ42/Aβ40, ApoE status, and age to predict brain amyloidosis. The APTUS-Aβ test received Breakthrough Device Designation from the FDA in early 2019 and is being positioned for clinical use under CLIA. C2N was formed by scientists from Washington University School of Medicine in St. Louis and LifeTech Research and operates a CLIA-certified clinical laboratory facility in St. Louis, Missouri. The company also developed a portfolio of anti-tau antibodies and formed a global partnership with AbbVie in March 2015 to develop and commercialize those assets. With the new funding, C2N plans to establish a premium quality patient testing service, pursue an IVD label with the FDA, and seek reimbursement from CMS while expanding its global growth and diagnostic pipeline.

Total raised

$57M

Funding rounds

4

Latest round

Equity

Latest activity

Sep 2024