On World Alzheimer’s Day, C2N Diagnostics’ PrecivityAD2™ Blood Test Expands Reach

ST. LOUIS--(BUSINESS WIRE)-- C₂N Diagnostics, a leader in advanced brain health diagnostics, is marking World Alzheimer’s Day by highlighting the growing international availability of the PrecivityAD2 blood test, a clinical care assay that helps healthcare providers identify amyloid plaques in the brain, which are recognized as key indicators of Alzheimer’s disease. Research has shown that PrecivityAD2 results closely match those from PET scans and spinal taps, the long-standing Alzheimer’s disease diagnostic tools that are seen as costly, invasive and not widely available.

Building on the success of the PrecivityAD2 blood test launch in the United States this summer, C₂N’s making the test available in Brazil through its partnership with Grupo Fleury, one of that country’s leading healthcare companies. Healthcare providers in Brazil can order the test through their existing ties to Grupo Fleury.

Brazilian government data estimates that 1.2 million people in the country suffer from Alzheimer’s disease and experts say a large number of people affected by this condition have not yet received a formal diagnosis.

Dr. Aurélio Pimenta Dutra, Fleury’s medical advisor for neurology, says, “I’m glad we’re able to offer the PrecivityAD2 blood test from C₂N Diagnostics, which has really set itself apart as a leader in this sector. The PrecivityAD2 blood test is helping healthcare providers determine the presence or absence of amyloid plaques in the brain, a hallmark sign of Alzheimer’s disease. It also aids providers in making medical management and treatment decisions. This is especially important as the existing diagnostic tools have many limitations. Patients facing cognitive impairment issues and their families face many stresses so I’m always glad to be able to help them find new ways to navigate the situation.”

C₂N Says the PrecivityAD2 Blood Test Helps to Set a New Standard for Alzheimer’s Disease Diagnosis

C₂N Diagnostics uses highly sensitive and specialized laboratory technologies to identify and detect certain amyloid beta and tau protein fragments, called peptides, that circulate in the blood and that are known to be associated with the presence of brain amyloid plaques. The main test result is a score, called the Amyloid Probability Score 2 (APS2).

The PrecivityAD2 blood test is designed to alleviate the bottleneck and unmet needs of healthcare providers and patients in evaluating patients with signs and symptoms of Alzheimer’s disease and other causes of cognitive decline. In a clinical validation study involving two independent cohorts totaling 583 patients with cognitive impairment using amyloid PET as the reference standard, the PrecivityAD2 blood test achieved an overall test performance statistic of 0.94 AUC and 88% accuracy.

The PrecivityAD2 blood test is bolstered by research from Dr. Sebastian Palmqvist and his colleagues at Lund University in Sweden with the BioFINDER-Primary Care and Memory Care studies that involved over 1,000 patients with cognitive concerns from four independent cohorts. His research presented at the 2023 Alzheimer’s Association International Conference outlined that this blood test had very high accuracy (AUC 0.95-0.97) for identifying Alzheimer’s disease pathology, primarily using CSF biomarkers as the reference standard.

Dr. Joel Braunstein, C₂N Diagnostics’ CEO, says, “We’ve received very strong interest from healthcare providers, patients and families in the PrecivityAD2 test in the short time it’s been available. We believe the PrecivityAD2 test is the next generation in blood biomarker tests and helps to establish a new standard in Alzheimer’s disease diagnosis because of its high concordance with PET scans and spinal taps. It’s an important step to be able to offer the PrecivityAD2 blood test in Brazil, as we all recognize an insidious disease like Alzheimer’s represents a global healthcare crisis in need of innovative solutions.”

C₂N’s Growing Global Footprint

C₂N continues to build on its international initiatives. Its partnership with Healius, one of Australia’s leading listed healthcare companies, aims to bring C₂N’s PrecivityAD2 blood test and related brain health biomarkers to the forefront of memory and dementia care in that country.

The company also is participating in the Global Health Care Preparedness Project with the Davos Alzheimer’s Collaborative, where Brazil is one of six countries with sites that rely on C₂N’s PrecivityAD® blood test to increase timely, accurate diagnosis of Alzheimer’s.

All Precivity™ tests must be ordered by an authorized healthcare provider; patients in the United States can easily schedule a blood draw appointment from C₂N’s network of over 700 patient service centers and 13,000 mobile phlebotomists.

The C₂N laboratory is a CLIA-certified, CAP-accredited laboratory that performs the Precivity tests as Laboratory Development Tests (LDT). C₂N received a Breakthrough Device Designation from the U.S. Food and Drug Administration in 2018. C₂N is the preferred diagnostics provider by over 20 leading biopharmaceutical companies.

About C₂N Diagnostics, LLC

C₂N is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. 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.

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