C2N Diagnostics, 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 an investment of up to $7.025 million from the Alzheimer’s Drug Discovery Foundation’s (ADDF) Diagnostics Accelerator initiative – which is focused on efforts to develop biomarkers and novel diagnostic technologies that aid in the early detection and diagnosis of Alzheimer’s and clinical trial design.
C2N looks 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. And the company says it will create an end-to-end platform, including instruments and diagnostic kits, that will enable leading research and clinical labs worldwide to aid healthcare providers in detecting fluid biomarkers that reflect core brain pathologies of Alzheimer’s disease.
This 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 various brain diseases.
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.
The Journal of the American Medical Association recently published research that showed the PrecivityAD2 test delivered a highly statistically significant accuracy of over 90% at a pre-defined and single binary cutoff compared to cerebrospinal fluid (CSF) analysis or amyloid PET analysis; the company’s LC-MS platform played an essential role in this outcome.
The global scalability project will run simultaneously with existing testing at the C2N laboratory in St. Louis, which is a CLIA-certified, CAP-accredited laboratory that performs the Precivity tests as Laboratory Development Tests (LDT). This adds to other developments, including Unilabs and C2N signing a multi-year partnership agreement that will increase access to C2N’s Precivity portfolio of blood tests on an exclusive basis in Europe, including Norway, Switzerland, and the United Kingdom. The agreement will also provide access in Peru, Saudi Arabia, and the United Arab Emirates.
C2N has also 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. And 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 have to be ordered by an authorized healthcare provider. And 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.
KEY QUOTES:
“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.”
- Dr. Howard Fillit, Co-Founder and Chief Science Officer of ADDF
“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.”
- Niranjan Bose, PhD, B Pharm, Managing Director, Health and Life Sciences at Gates Ventures
“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.”
- C2N CEO Dr. Joel Braunstein
