New Research Reinforces C2N’s PrecivityAD2™ Blood Test as a Highly Accurate Tool to Detect Brain Amyloid Pathology in Symptomatic Patients

ST. LOUIS--(BUSINESS WIRE)--C2N Diagnostics, LLC (“C2N”), a specialty diagnostics company with a vision to bring Clarity Through Innovation®, is highlighting a peer-reviewed study that independently validates the performance of the PrecivityAD2™ blood test among individuals with mild cognitive impairment or dementia.

C2N CEO and President Dr. Joel Braunstein says, “The latest research adds to the growing body of literature that shows the PrecivityAD2 test effectively confirms Alzheimer’s disease pathology."

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The research states that the PrecivityAD2™ blood test demonstrated 91% accuracy, 90% sensitivity and 92% specificity using the CLIA-established cutoff versus amyloid PET imaging, which healthcare professionals have traditionally had to rely on to make an Alzheimer’s disease diagnosis. C2N says the outcome confirms the test’s “repeatable, reliable and robust” performance.

The research appears in npj Dementia, which is part of the Nature Portfolio.

C2N also stresses that the PrecivityAD2 results are consistent with current expert recommendations, including the 2025 Alzheimer’s Association’s Clinical Practice Guidelines for confirmatory blood biomarker tests (≥90% accuracy/sensitivity/specificity).

C2N CEO and President Dr. Joel Braunstein says, “The latest research adds to the growing body of literature that shows the PrecivityAD2 test effectively confirms Alzheimer’s disease pathology. This is more vital than ever as patients with mild cognitive impairment due to Alzheimer’s disease are very eager to access the new disease-modifying therapies, and scientists have stated these therapies are most successful when they start early.”

Braunstein adds that the Journal of the American Medical Association (JAMA) also published a large clinical study examining the ability of the PrecivityAD2™ blood test to improve the diagnostic accuracy of Alzheimer’s disease in primary care settings, where most patients with cognitive concerns turn to for initial answers about their memory loss.

The study found similar robustness for the PrecivityAD2 test result in patients who saw memory care specialists. The PrecivityAD2 test algorithm 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.

C2N’s PrecivityAD2 blood test combines plasma Aβ42/40 and %p-tau217 biomarkers into the Amyloid Probability Score™ (APS2™) algorithm to aid in detecting the presence or absence of brain amyloid pathology in individuals with signs or symptoms of cognitive impairment undergoing evaluation for Alzheimer’s disease or other causes of cognitive decline.

The Precivity tests are available in 49 states in the U.S., excluding New York (where certification is pending), as well as the District of Columbia and Puerto Rico. C2N also recently signed additional global partners to broaden access in Asia, Latin America, Europe and the Middle East.

C2N’s Precivity tests for patient care are performed under the ISO 13485:2016 standard and in the company’s CAP accredited, CLIA certified laboratory.

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, Alzheimer’s Association, and The Michael J. Fox Foundation. For more information visit www.c2n.com.