C2N Funded by Diagnostics Accelerator for Global Alzheimer's Mass Spectrometry Solution

C2N Diagnostics, LLC, a global frontrunner in Alzheimer’s disease diagnostic blood tests, is working on a comprehensive, automated, and standardized high-resolution liquid chromatography-mass spectrometry (LC-MS) platform. This platform aims to facilitate the deployment of their innovative clinical and research biomarkers in laboratories worldwide. This initiative is bolstered by a significant investment of up to $7.025 million from the Alzheimer’s Drug Discovery Foundation’s (ADDF) Diagnostics Accelerator initiative, which supports the development of breakthrough biomarkers and diagnostic technologies for early detection and diagnosis of Alzheimer’s.

C2N's ultimate goal is to revolutionize Alzheimer’s disease diagnosis and enhance medical management and treatment by meeting an unmet clinical need through their high-performance LC-MS solution. The company plans to develop a comprehensive platform that includes both instruments and diagnostic kits. This will enable research and clinical labs globally to help healthcare providers detect fluid biomarkers that indicate core brain pathologies associated with Alzheimer’s disease.

The initiative will support multiple assays that track both amyloid and tau pathology and will provide a framework for incorporating future C2N assays targeting various measures of neuropathology related to multiple brain diseases. C2N emphasizes that this decentralized, high-performance testing process, developed in compliance with regulatory standards, is crucial to meet the growing global demand for early and accurate disease detection.

Recent research published in the Journal of the American Medical Association highlights the effectiveness of C2N’s PrecivityAD2™ test, showing over 90% accuracy compared to cerebrospinal fluid (CSF) analysis or amyloid PET analysis. Dr. Howard Fillit, Co-Founder and Chief Science Officer of ADDF, praised the Precivity blood tests as essential, cost-effective, and accessible diagnostic tools for memory and dementia care. He noted that the new investment in C2N’s LC-MS testing platform would bring us closer to a future where blood tests are a reliable method for diagnosing Alzheimer’s disease.

Niranjan Bose, Managing Director of Health and Life Sciences at Gates Ventures, acknowledged C2N’s impressive track record in the field of high-performance blood biomarkers for early Alzheimer’s diagnosis. He stated that this investment supports efforts to diagnose the disease earlier, promote a diverse drug pipeline, accelerate clinical trial enrollment, and facilitate data sharing. The development and validation of a clinical lab workstation alongside Precivity diagnostic test kits could be transformational.

C2N CEO Dr. Joel Braunstein noted that early and accurate detection is vital for transforming Alzheimer’s trajectory through early treatment and prevention. He expressed gratitude to the Diagnostics Accelerator for their support and confidence in C2N’s approach. Dr. Braunstein stated that the project aims to redefine high-performance Alzheimer’s disease testing globally, highlighting the significant potential reach of their LC-MS clinical analyzer, which can process their proprietary Precivity™ tests. Many research and clinical labs worldwide have already shown interest in adopting their tests.

This global scalability project will run alongside existing testing at C2N’s laboratory in St. Louis, a CLIA-certified, CAP-accredited lab performing the Precivity tests as Laboratory Development Tests (LDT). This development comes during World Alzheimer’s Month and follows other significant milestones, including a multi-year partnership agreement with Unilabs to increase access to C2N’s Precivity™ blood tests in Europe and other regions. Additionally, C2N has entered a non-exclusive agreement with Mayo Clinic Laboratories to include Precivity tests in their offerings.

C2N Diagnostics received a Breakthrough Device Designation from the U.S. Food and Drug Administration in 2018 and is a preferred diagnostics provider for leading biopharmaceutical companies worldwide. All Precivity tests must be ordered by authorized healthcare providers, and patients in the U.S. can schedule blood draw appointments through C2N’s extensive network.

C2N Diagnostics is a specialty diagnostics company dedicated to providing advanced diagnostic solutions for brain health, with a focus on Alzheimer’s disease. Their high-resolution mass spectrometry-based biomarker services and products are designed to improve patient care, enhance clinical trials, and support healthcare research.