ST. LOUIS--(BUSINESS WIRE)--C2N Diagnostics, LLC (C2N), a world leader in developing Alzheimer’s disease-specific fluid biomarker tests, has received a new $15 million program-related investment from GHR Foundation (GHR) to support the next generation of tests specific to tau tangle pathology. Tau tangles represent an integral component of Alzheimer’s disease pathology and are believed to play an important role in clinical progression of the disease.
This next generation of tests offers a potential alternative to invasive, costly, and often inaccessible tau PET tracers. The new tests will focus on a combination of tau-based blood biomarkers, including MTBR-tau, which are important indicators of pathological tau tangles and neurites associated with Alzheimer’s disease. These blood biomarkers may aid in differential diagnosis of clinical Alzheimer’s disease among people with cognitive symptoms, biologically stage the disease, and help inform the development of tau-directed therapeutics by providing insights into tau pathology.
“Our innovative, precision medicine-focused work has already galvanized the science, the research, and the platform for developing and commercializing novel diagnostics. Now, we’re poised to add tests for tau-based blood biomarkers to our Alzheimer’s disease testing portfolio,” said C2N’s CEO Dr. Joel Braunstein. “The real benefit of this C2N-GHR collaboration will be seen by patients, families, and health systems currently impacted by the wrath of Alzheimer’s disease.”
Previously, C2N responded to research and industry interest by introducing a proprietary cerebrospinal fluid test for research use only that can measure MTBR-tau.
GHR Foundation funding is in addition to the recent announcement that C2N has received a groundbreaking investment up to $7.025 million from the Alzheimer’s Drug Discovery Foundation’s (ADDF) Diagnostics Accelerator initiative. The Diagnostics Accelerator investment is devoted to developing a decentralized clinical mass spectrometry solution to enable high-performance Alzheimer’s disease testing worldwide.
GHR Foundation’s Support Integral to the PrecivityAD2™ Test’s Launch
Previous GHR funding supported C2N’s current generation blood test, the PrecivityAD2 test, which was released in 2023 for use in clinical care. Recently, the Journal of the American Medical Association published widely acclaimed research showing that the PrecivityAD2 test delivers confirmatory diagnostic performance comparable to CSF biomarkers and amyloid PET in detecting brain amyloid pathology.
“C2N’s tests are establishing a new gold standard for Alzheimer’s Disease diagnosis,” said CEO and GHR board Chair Amy Rauenhorst Goldman. “We are confident in C2N’s efforts to tackle tau detection in the blood to achieve a more comprehensive picture of Alzheimer’s pathology at any stage of disease.”
The study noted the PrecivityAD2 blood test achieved an accuracy of 90% or higher among the patients regardless of whether they received their care in either the primary care or secondary care settings. In contrast, using standard of care evaluation tools like history, physicals, routine blood tests, and imaging, primary care doctors correctly diagnosed Alzheimer’s in only 61% of patients, and memory specialists only had a 73% accuracy rate.
“Our next generation of tests for tau tangle pathology will build on the demand we’ve seen with our other Precivity™ tests,” said Braunstein.
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 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 primarily across Europe, 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 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.
