C2N Diagnostics, LLC, an international leader with its Precivity blood tests to help diagnose Alzheimer’s disease, aims to create a fully automated, standardized, high resolution liquid chromatography-mass spectrometry (LC-MS) platform to enable the local deployment of the precise innovation at the core of its clinical and research biomarkers in clinical labs around the world.
C2N has received a groundbreaking investment up to $7.025 million from the Alzheimer’s Drug Discovery Foundation’s (ADDF) Diagnostics Accelerator initiative, which is focused on efforts to develop cutting-edge biomarkers and novel diagnostic technologies that aid in the early detection and diagnosis of Alzheimer’s and clinical trial design.
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C2N seeks to transform Alzheimer’s disease diagnosis and inform medical management and treatment decisions by addressing an unmet clinical need through its high-performance LC-MS solution. The company says it will create an end-to-end platform, including instruments and diagnostic kits, that will enable leading research and clinical labs around the world to aid healthcare providers in the detection of fluid biomarkers that reflect core brain pathologies of Alzheimer’s disease.
Dr. Howard Fillit, Co-Founder and Chief Science Officer of ADDF, says, “C2N’s Precivity blood tests answer a critical need for less costly and more accessible diagnostic testing in memory and dementia care. Their tests are highly sensitive and accurate clinical tools that aid healthcare providers in the diagnosis and treatment of Alzheimer’s disease. This new investment in C2N’s LC-MS clinical testing platform brings us closer to the day when even more patients will be able to rely on blood tests to help diagnose Alzheimer’s disease.”
The initiative will accommodate multiple assays tracking both amyloid and tau pathology and enable a framework for adding future C2N assays targeting different measures of neuropathology implicated in multiple brain diseases.
Niranjan Bose, PhD, B Pharm, Managing Director, Health and Life Sciences at Gates Ventures, says, “C2N’s impressive track record includes establishing itself as a leading innovator in the field of high-performance blood biomarkers that are playing a pivotal role in the early diagnosis of Alzheimer’s disease. This investment furthers our aim to address the global burden of Alzheimer’s disease by supporting efforts to diagnose the disease earlier, catalyze a more diverse drug pipeline, accelerate clinical trial enrollment, and facilitate data sharing. The approach to develop and validate a clinical lab workstation along with Precivity diagnostic test kits could be a game-changer.”
C2N believes this decentralized process for high-performance testing, developed and qualified in a regulatory-compliant manner, is a requisite to address the growing global demand for early and accurate disease detection.
C2N CEO Dr. Joel Braunstein says, “Early and accurate detection represents the greatest chance for transforming the trajectory of Alzheimer’s disease through early treatment and prevention. We thank the Diagnostics Accelerator for their trust and confidence in our approach. This project aims to truly redefine what it means to offer high-performance Alzheimer’s disease testing on a global scale. We believe the potential reach of our scale-up achievable through an LC-MS clinical analyzer that can run our proprietary portfolio of Precivity™ tests is significant. Many research and clinical labs at locations throughout the world have already expressed interest in adopting our tests. We look forward to working with these groups in the years ahead as we seek to make that aspiration a reality.”
In addition, C2N has entered into a non-exclusive agreement with Mayo Clinic Laboratories, for inclusion of C2N’s Precivity tests in Mayo Clinic Laboratories’ test offerings to its clients.
C2N received a Breakthrough Device Designation from the U.S. Food and Drug Administration in 2018. C2N is a preferred diagnostics provider by many of the leading biopharmaceutical companies throughout the world.
All Precivity tests must be ordered by an authorized healthcare provider; patients in the United States can easily schedule a blood draw appointment from C2N’s network of over 700 patient service centers and 13,000 mobile phlebotomists.
About C2N Diagnostics, LLC
C2N Diagnostics is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C2N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health.
