Next Generation Assays Provide Unique Insights into Neurofibrillary Tangles, Disease Progression, and Novel Treatments for Better Precision Medicine

C2N Diagnostics, LLC, a pioneer in advanced diagnostic testing for brain health, announces the launch of two new highly anticipated plasma assays for Research Use Only: C2N eMTBR-tau243 and C2N %p-tau MAA.

C2N eMTBR-tau243 (endogenous Microtubule Binding Region) is a unique blood test that selectively detects a specific region of tau; this fragment has been shown to closely track insoluble tau aggregates within neurofibrillary tangles in Alzheimer’s disease. C2N cites research that says this may provide the potential to improve the diagnostic evaluation of Alzheimer’s pathology in clinical trials, supporting essential disease staging, predicting disease progression and response to treatment, and monitoring treatment efficacy.

This new plasma assay builds on the existing C2N eMTBR-tau243 test in cerebrospinal fluid launched by C2N nearly two years ago and is available for Research Use Only. C2N obtained the exclusive rights for these technologies from the Bateman Lab at WashU Medicine. With funding from the GHR Foundation, the C2N team optimized and industrialized these assays using rigorous analytical methods to bring them to their current state.

The company aims to integrate the new plasma C2N eMTBR-tau243 assay into clinical routine in the future.

C2N Increases Diagnostic Power With C2N %p-tau MAA

C2N is also launching a novel p-tau multi-analyte assay (MAA). This assay uses high-resolution mass spectrometry (LC-MS/MS) to precisely quantitate six analytes related to phosphorylated and nonphosphorylated forms of tau (%p-tau181, %p-tau205 and %p-tau217). The C2N %p-tau MAA measures multiple phosphorylated tau forms from a single sample and, therefore, enables greater efficiencies. This test is likewise available for Research Use Only.

C2N's LC-MS/MS methodologies enable a ratio of phosphorylated tau divided by non-phosphorylated tau (%p-tau) that previously has been shown to mitigate for confounding factors such as age and medical comorbidities like kidney disease. The Journal of the American Medical Association (JAMA) published a large clinical study that found C2N’s PrecivityAD2™ test accuracy was not impacted in the primary care arm of the study despite having patients of older age and with higher prevalence of comorbidities.

The company believes the C2N %p-tau MAA and C2N eMTBR-tau243 assays will play a key role in biopharma clinical trials, enabling better assessment of Alzheimer’s disease pathology and supporting a precision medicine approach to novel treatment strategies. The assays will cover both early-stage and late-stage tau pathology identification, providing a robust marker for disease identification, staging, and stratification.

“Our introduction of the C2N eMTBR-tau243 blood test and the C2N %p-tau MAA demonstrates C2N’s commitment to clinically-relevant innovations and advancing brain health diagnostics, first as Research Use Only tools and then in the form of clinical diagnostic tests,” says C2N CEO and President Dr. Joel Braunstein. “Patients and families worried about Alzheimer’s disease are pressing on the entire healthcare sector for a clearer picture of Alzheimer's disease pathology. We are responding, first for researchers and then for the broader global healthcare provider community.”

The Precivity™ line of blood tests currently available clinically to 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 are: PrecivityAD®, PrecivityAD2™, and Precivity-AopE™.

About C2N Diagnostics, LLC

C2N 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 in addition to research and distribution partnerships with leading labs around the world including Grupo Fleury, Healius, Mediford, Mayo Clinic Laboratories, and Unilabs. Over 50,000 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250715238954/en/

“Our introduction of the C2N eMTBR-tau243 blood test and the C2N %p-tau MAA demonstrates C2N’s commitment to clinically-relevant innovations and advancing brain health diagnostics," says C2N CEO and President Dr. Joel Braunstein.