C2N Diagnostics Licenses and Introduces Novel Fluid Biomarker for Alzheimer’s Disease
C2N Diagnostics has announced the launch of a proprietary biomarker test, designed for Research Use Only (RUO) for Alzheimer’s disease. The test measures the microtubule binding region of tau (MTBR-tau), providing a unique way to detect the presence and burden of neurofibrillary “tau” tangles (NFTs) that consist of aggregated tau proteins in the brain. It is poised as a potential alternative to invasive, costly, and often inaccessible tau PET tracers.
MTBR-tau plays a crucial role in tau protein aggregation and serves as a core component of NFTs, which are one of the pathological hallmarks that accumulate in the brains of individuals with Alzheimer’s disease (AD). This fluid biomarker, MTBR-tau, has applications in the diagnosis of AD, disease staging, and the development of tau-directed therapeutics. Furthermore, MTBR-tau biomarkers show promise in advancing the diagnosis of non-AD tauopathies, such as corticobasal degeneration (CBD), frontotemporal dementia (FTD), and progressive supranuclear palsy (PSP).
The availability of the RUO test allows industry and clinician researchers to delve deeper into studying improved methods for diagnosing, monitoring investigational treatment responses, and comprehending the underlying biological mechanisms of AD. Ultimately, C2N intends to leverage its extensive biomarker expertise, vast library of molecular, imaging, and clinical data, and predictive analytical capabilities to further develop and commercialize these novel biomarkers for clinical care.
Dr. Joel Braunstein, CEO of C2N, emphasizes, “This development underscores the company’s commitment to building upon its long-established partnership with Washington University. Together, we aim to deliver 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 secured exclusive, worldwide, commercial license rights for the MTBR-tau technologies from Washington University in St. Louis. Data on this biomarker has been published in Nature Medicine, titled “CSR MTBR-tau243 is a specific biomarker of tau tangle pathology in Alzheimer’s disease.” The study found that MTBR-tau243 demonstrates a strong association with tau pathology, particularly neurofibrillary “tau” tangles (NFTs) that characterize Alzheimer’s disease. The study reveals that MTBR-tau243 not only reflects late-stage AD progression but also showcases a higher correlation with cognitive measures compared to phosphorylated tau markers. By combining MTBR-tau243 with other markers, the study authors believed the marker could be a powerful tool for predicting tau and amyloid pathologies, cognitive impairment, and AD diagnosis, potentially serving as a less costly and more accessible alternative to PET imaging.