First Canadian Clinic to Offer C2N’s PrecivityAD2™ Blood Test to Help Healthcare Providers Diagnose Alzheimer’s Disease, Joining Global Community in Embracing Breakthrough Technology
ST. LOUIS — Jan. 28, 2025 — People in Canada concerned about their memory loss or their loved ones’ issues now have a new option to aid in diagnosis. Toronto Memory Program (TMP) is the first clinic in the country to offer the PrecivityAD2™ blood test from C2N Diagnostics, LLC (“C2N”). This blood test allows healthcare providers to determine the presence or absence of amyloid pathology, a known hallmark of Alzheimer’s disease, through a simple, non-invasive approach. Other Canadian clinics are expected to soon join TMP in making the test available.
The prevalence of Alzheimer’s disease in Canada is estimated at over 600,000 people, with even higher numbers of people at the mild cognitive impairment stage of the disease. Researchers have highlighted that there may be as many as 382,000 people in Canada waiting to receive a confirmatory Alzheimer’s disease diagnosis; the long waits are largely due to a lack of specialists and insufficient diagnostic infrastructure such as amyloid PET scanners.
C2N says the PrecivityAD2 blood test can resolve some of these hurdles. The PrecivityAD2 test involves a simple blood draw from the patient and is intended for patients aged 55 and older with signs or symptoms of mild cognitive impairment or dementia who are undergoing evaluation for Alzheimer's disease or other causes of cognitive decline.
Toronto Memory Program’s Leading Role in Canada
TMP is a multidisciplinary, community-based medical facility specializing in the diagnosis and treatment of Alzheimer’s disease and related disorders; it has one of the largest memory clinics and clinical trial programs for Alzheimer’s disease in Canada.
Dr. Sharon Cohen, Behavioural Neurologist and Medical Director of TMP, says, “For far too long, early and accurate diagnosis of Alzheimer’s disease has been inaccessible to most Canadians due to reliance on expensive PET scans or lumbar punctures. This situation is untenable as emerging Alzheimer’s treatments require early diagnosis and biological confirmation. We are excited to offer our patients the option of C2N’s PrecivityAD2 as this easily accessible and highly accurate blood test helps us to determine whether Alzheimer’s disease is present in the brain, and to treat accordingly.”
Dr. Joel Braunstein, CEO of C2N Diagnostics, says, “Dr. Cohen and the Toronto Memory Program are renowned for the quality of care they provide their patients. We believe they are a perfect fit for the expanding group of global healthcare providers that offer the PrecivityAD2 blood test. The growing burden of Alzheimer’s disease requires all healthcare providers to explore new ways to offer less costly and more accessible diagnostic testing in memory and dementia care. We are delighted to be collaborating with Dr. Cohen and her team, and we look forward to other partnerships in Canada very soon.”
PrecivityAD2 Blood Test is Rigorously Analytically and Clinically Validated; Has High Accuracy
The Journal of the American Medical Association (JAMA) recently published a large clinical care study examining the ability of the PrecivityAD2 blood test algorithm 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 the PrecivityAD2 test result 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.
The PrecivityAD2 blood test uses uniquely specialized laboratory technologies to precisely identify and measure certain proteins that are found in the blood and that are known to be associated with the presence of brain amyloid plaques, a core pathological hallmark of Alzheimer’s disease. The main test result is a score that determines a patient’s likelihood category for the presence of brain amyloid plaques.
All of C2N’s Precivity™ tests are currently performed under the ISO 13485:2016 standard and in the company’s CAP accredited, CLIA certified laboratory.
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About C2N Diagnostics, LLC
C2N Diagnostics 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 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 30,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review.
C2N has partnered with numerous leading clinical diagnostic labs throughout the world to offer expanded Precivity™ testing access to providers and patients, including Unilabs primarily across Europe and the United Kingdom, Grupo Fleury in Brazil and Healius Pathology in Australia for clinical use, and with Mediford Corporation in Japan for research purposes. C2N also recently announced it entered into a non-exclusive agreement with Mayo Clinic Laboratories.
The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, Alzheimer’s Association, Michael J Fox Foundation, and BrightFocus Foundation. For more information visit www.C2N.com.
C2N CONTACT:
C2N MEDIA CONTACT:
Adam Shapiro
202-427-3603
TORONTO MEMORY PROGRAM CONTACT:
Michelle Martinez, Clinic Manager
Michelle.martinez@memorydisorders.ca
416-386-9761, extension 307