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ST. LOUIS--( BUSINESS WIRE )-- 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. 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. 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. 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. Landmark Research Highlights Effectiveness of C2N’s Precivity Blood Tests for Alzheimer’s Disease Diagnosis 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, 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. 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.” 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 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.” The global scalability project will run concurrently 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 news, occurring during World Alzheimer’s Month, 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. 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. C2N’s high-resolution mass spectrometry-based biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. C2N assays have been used in over 150 Alzheimer’s disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies (DMTs) that are changing the trajectory of Alzheimer’s disease. C2N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer’s Association, and other non-profits and consortiums. Over 30,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review. C2N has partnered with numerous leading clinical diagnostic labs throughout the world to offer expanded Precivity™ testing access to providers and patients, including Unilabs across 75 countries, Grupo Fleury in Brazil and Healius Pathology in Australia for clinical use, and with Mediford Corporation in Japan for research purposes. C2N also recently announced it has entered into a non-exclusive agreement with Mayo Clinic Laboratories. The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, Alzheimer’s Association and BrightFocus Foundation. For more information visit www.C2N.com . About Precivity™ Tests The Precivity™ tests are innovative new blood tests intended for use in patients 55 and older with signs or symptoms of mild cognitive impairment or dementia. These tests aid healthcare providers in the detection of amyloid plaques in the brain, a pathological hallmark of Alzheimer's disease, and inform medical management and treatment decisions. About Mass Spectrometry A mass spectrometer is a device that produces charged particles (ions) from biological substances and biomarkers present in complex tissues and fluids like blood. The platform then uses electric and magnetic fields to measure the mass of the charged particles. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) offers advantages of true multiplexing, quantitative accuracy, high sensitivity, high specificity, and wide dynamic range, enabling definitive identification and quantification of Alzheimer’s disease biomarkers at both low and high abundance. High resolution LC-MS/MS is an ideal platform to evaluate multiple complex biomarkers simultaneously to help optimize diagnostic accuracy. About The Alzheimer’s Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $290 million to fund over 750 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 20 countries. To learn more, please visit: http://www.alzdiscovery.org/ . About The Diagnostics Accelerator (DxA) The Diagnostics Accelerator, created in July 2018, is a $100 million global research initiative from partners including ADDF Co-Founder Leonard A. Lauder, Bill Gates, Jeff Bezos, MacKenzie Scott, the Dolby family, the Charles and Helen Schwab Foundation, The Association for Frontotemporal Degeneration, among others, to develop novel biomarkers for the early detection of Alzheimer's disease and related dementias. This research initiative is dedicated to accelerating the development of affordable and accessible biomarkers to diagnose Alzheimer's disease and related dementias and advance the clinical development of more targeted treatments. Through translational research awards and access to consulting support from industry experts, this program will challenge, assist and fund the research community in both academia and industry to develop novel peripheral and digital biomarkers.

New investment supports DxA's mission to advance the development of scalable and universally accessible diagnostics. Blood tests will be key to further evolving Alzheimer's diagnostics, care, and research. NEW YORK, Sept. 25, 2024 /PRNewswire/ -- The Alzheimer's Drug Discovery Foundation (ADDF) today announced a new investment in C2N Diagnostics. The $7 million investment is the largest to date from the ADDF's Diagnostics Accelerator (DxA) and underscores the DxA's commitment to developing and deploying novel biomarkers, including blood tests, that will transform the Alzheimer's diagnostic landscape, a core tenet of the ADDF's mission. Scalable, accessible blood-based biomarkers will be critical to enabling a combination therapy and precision medicine approach in Alzheimer's, like in cancer care. "Blood tests are transforming Alzheimer's disease detection and will continue to play a critical role in the future of Alzheimer's treatment and research," notes Howard Fillit, MD, Co-Founder and Chief Science Officer at the ADDF. "PTau217 has emerged as the blood-based biomarker gold standard for diagnostic purposes and studies show that C2N's PrecivityAD2® test has industry-leading sensitivity and accuracy, positioning these tests to replace more invasive PET scans and spinal taps. This investment will improve this critical tool's accessibility, a pillar of the DxA's mission to develop diagnostics for the millions of patients living with this disease." C2N's pioneering blood tests are rooted in scientific rigor with a history of breakthroughs. Notably, the company's PrecivityAD® blood test was first-to-market with the help of ADDF seed-funding. With this new investment, C2N intends to develop a deployable version of its blood biomarker detection platform, like well-known diagnostics platforms such as Roche's Elecsys and Fujirebio's Lumipulse, that will enable global access to the test. This investment builds upon the ADDF and C2N's longstanding partnership. "C2N Diagnostics gratefully appreciates the Alzheimer's Drug Discovery Foundation's DxA for their trust and confidence in our approach and for providing this critical funding. We recognize the significance of being the largest recipient to date of DxA funding and take that responsibility very seriously," says Joel Braunstein, MD, CEO and Co-Founder of C2N. "We're intensely focused on our goal to develop an end-to-end clinical mass spectrometry solution. This platform will enable high-performance Alzheimer's disease testing on a global scale. C2N believes a 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." Blood-based biomarkers are one part of the DxA's diverse portfolio, which also includes ocular tests and digital tools. To date, the DxA has invested more than $70 million in over 60 projects. Along with blood tests, the future of Alzheimer's diagnostics will incorporate digital and ocular tools that will not only provide patients with early and accurate diagnoses, but also have the potential to be used for screening, prognostic, and prevention efforts. "Sensitive and accurate biomarkers are crucial to support early diagnosis and intervention, which studies show can have considerable impact on disease progression," says Niranjan Bose, PhD, B Pharm, Managing Director of Health & Life Sciences at Gates Ventures. "The true measure of the value of a biomarker is whether it's accessible and scalable enough to promote adoption and subsequently transform the diagnostic landscape—which is what we hope to do here." Advancements in Alzheimer's blood tests will help accelerate drug development and clinical trials by providing faster and more cost-effective ways to enroll patients into trials and will aid in monitoring the target engagement of new drugs. Ultimately, blood tests and novel biomarkers will support the future of combination therapy and precision medicine—the holy grail of Alzheimer's treatment. ABOUT THE ALZHEIMER'S DRUG DISCOVERY FOUNDATION (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $290 million to fund over 750 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 20 countries. To learn more, please visit: . ABOUT THE DIAGNOSTICS ACCELERATOR (DxA) The Diagnostics Accelerator, created in July 2018, is a $100 million global research initiative from partners including ADDF Co-Founder Leonard A. Lauder, Bill Gates, Jeff Bezos, MacKenzie Scott, the Dolby family, the Charles and Helen Schwab Foundation, The Association for Frontotemporal Degeneration, among others, to develop novel biomarkers for the early detection of Alzheimer's disease and related dementias. This research initiative is dedicated to accelerating the development of affordable and accessible biomarkers to diagnose Alzheimer's disease and related dementias and advance the clinical development of more targeted treatments. Through translational research awards and access to consulting support from industry experts, this program will challenge, assist and fund the research community in both academia and industry to develop novel peripheral and digital biomarkers. 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. C2N's high-resolution mass spectrometry-based biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. C2N assays have been used in over 150 Alzheimer's disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies (DMTs) that are changing the trajectory of Alzheimer's disease. C2N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer's Association, and other non-profits and consortiums. Over 30,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review. C2N has partnered with numerous leading clinical diagnostic labs throughout the world to offer expanded Precivity™ testing access to providers and patients, including Unilabs across 75 countries, Grupo Fleury in Brazil and Healius Pathology in Australia for clinical use, and with Mediford Corporation in Japan for research purposes. C2N also recently announced it has entered into a non-exclusive agreement with Mayo Clinic Laboratories. The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer's Drug Discovery Foundation, Alzheimer's Association and BrightFocus Foundation. For more information visit . ABOUT PRECIVITY™ TESTS The Precivity™ tests are innovative new blood tests intended for use in patients 55 and older with signs or symptoms of mild cognitive impairment or dementia. These tests aid healthcare providers in the detection of amyloid plaques in the brain, a pathological hallmark of Alzheimer's disease, and inform medical management and treatment decisions. ABOUT MASS SPECTROMETRY A mass spectrometer is a device that produces charged particles (ions) from biological substances and biomarkers present in complex tissues and fluids like blood. The platform then uses electric and magnetic fields to measure the mass of the charged particles. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) offers advantages of true multiplexing, quantitative accuracy, high sensitivity, high specificity, and wide dynamic range, enabling definitive identification and quantification of Alzheimer's disease biomarkers at both low and high abundance. High resolution LC-MS/MS is an ideal platform to evaluate multiple complex biomarkers simultaneously to help optimize diagnostic accuracy. SOURCE Alzheimer's Drug Discovery Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED