C₂N Diagnostics Introduces Next-Generation Fluid Biomarker to the Field of Alzheimer’s Disease: Test to Help Researchers Track Neurofibrillary “Tau” Tangle Pathology
ST. LOUIS — Oct. 25, 2023 — C2N Diagnostics, a leader in advanced brain health diagnostics, is responding to pharmaceutical industry interest by introducing a much-desired, proprietary biomarker test for Research Use Only (RUO) that can measure the microtubule binding region of tau (MTBR-tau). This analyte measurement was engineered with the intention of uniquely detecting the presence and burden of neurofibrillary “tau” tangles (NFTs) comprised of aggregated tau proteins in the brain and as a potential alternative to invasive, costly, and often inaccessible tau PET tracers.
MTBR-tau is critical for tau protein aggregation and is an enriched core component of NFTs, one of the pathological hallmarks that accumulate in the brain of individuals with Alzheimer’s disease (AD). The MTBR-tau fluid biomarker can be used in the diagnosis of AD, in disease staging, and in the development of tau-directed therapeutics. Furthermore, the MTBR-tau biomarkers have the potential to advance the diagnosis of non-AD tauopathies, such as corticobasal degeneration (CBD), frontotemporal dementia (FTD), and progressive supranuclear palsy (PSP).
The MTBR-tau addition expands C₂N’s pharmaceutical services offerings as well as its pipeline of novel biomarkers to address the increasing need for timely and accurate brain health evaluations of aging Americans and others around the world.
The RUO test availability allows leading industry and clinician researchers to further study ways to better diagnose, monitor investigational treatment responses, and understand AD’s underlying biological mechanisms. Ultimately, C₂N plans to leverage its vast biomarker expertise; internal library of molecular, imaging, and clinical data; and predictive analytical capabilities to further develop and commercialize the novel biomarkers for clinical care.
Dr. Joel Braunstein, C₂N’s CEO, says, “This development highlights how the company is building on its long-established history of successful partnership with Washington University to bring best-in-class biomarkers targeting AD and related forms of neurodegeneration to the healthcare sector. We are already forging collaborations with leading academic and industry colleagues to understand how MTBR-tau can aid in disease detection, staging, treatment monitoring, differential diagnosis, and risk assessment of AD and other tauopathies.”
C₂N acquired the exclusive, worldwide, commercial license rights to the MTBR-tau technologies from Washington University in St. Louis. Leaders in the development effort were Dr. Randall J. Bateman, the Charles F. and Joanne Knight Distinguished Professor of Neurology at Washington University School of Medicine and co-founder of C₂N, along with members of his lab: Kanta Horie, Ph.D., a visiting research associate professor; Nicolas R. Barthélemy, Ph.D., assistant professor of neurology; and Chihiro Sato, Ph.D., assistant professor of neurology. These investigators, along with distinguished researchers from Lund University in Sweden and Eisai Inc., published a seminal article on the findings of MTBR-tau243 in Nature Medicine titled: CSR MTBR-tau243 is a specific biomarker of tau tangle pathology in Alzheimer’s disease.
Dr. David M. Holtzman, the Barbara Burton and Reuben M. Morriss III Distinguished Professor of Neurology, co-founded C₂N with Dr. Bateman.
Nichole Mercier, Ph.D., assistant vice chancellor and managing director of the Office of Technology Management at Washington University in St. Louis, says, “We have a longstanding collaboration with C₂N, which was co-founded by our renowned Alzheimer’s researchers Drs. Bateman and Holtzman. C₂N is a leader in advancing innovative clinical diagnostics to improve the early diagnosis and treatment of Alzheimer’s disease, and our collaboration enables Washington University discoveries to become commercialized globally.”
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About C₂N Diagnostics, LLC
C₂N is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C₂N strives to provide exceptional laboratory services and products 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 100 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 15,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review.
The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, BrightFocus Foundation and Alzheimer’s Association. For more information visit www.C2N.com.
COMPANY CONTACT:
Joni Henderson
JHenderson@c2n.com
314-464-0009
MEDIA CONTACT:
Adam Shapiro
202-427-3603