PrecivityAD2 Test Delivers Confirmatory Diagnostic Performance That Is Comparable To CSF Biomarkers and Amyloid PET To Identify Presence or Absence of Brain Amyloid Pathology
Top-line Study Results To Be Presented During Opening Day at the Alzheimer’s Association International Conference (AAIC) 2024
ST. LOUIS-The Journal of the American Medical Association (JAMA) has published a large clinical study examining the ability of C2N Diagnostics, LLC’s (C2N) PrecivityAD2™ blood test to improve the diagnostic accuracy of Alzheimer’s disease (AD) 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 in patients who saw memory care specialists. The PrecivityAD2 test 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.
Dr. Sebastian Palmqvist says, “The results of this study support the idea that a high-performing blood test has the potential to revolutionize the diagnostic work-up of Alzheimer’s disease in primary care.”
The article, “Blood Biomarkers to Detect Alzheimer’s Disease in Primary Care and Secondary Care,” also states that these results involving over 1,200 patients were substantiated despite a relatively high rate of medical comorbidities such as cardiovascular disease, high cholesterol, chronic kidney disease, and diabetes among prospectively enrolled patients in both primary and secondary care.
Dr. Oskar Hansson, Professor of Neurology at Lund University in Sweden and senior author of the article, will present the top-line study findings on the opening day of AAIC 2024 in Philadelphia. He’ll explain that primary care physicians diagnosed Alzheimer’s disease pathology accurately only 61% of the time when they relied on the standard of care involving a clinical examination, cognitive testing and a CT scan.
The PrecivityAD2 test involves a single blood draw sample and then uses high-resolution mass spectrometry to precisely measure proteins in the blood that indicate the likelihood of amyloid plaques in the brain, a pathological hallmark of AD. It relies on a rigorously-validated algorithm that combines plasma Aβ42/40 and p-tau217/np-tau217 (%p-tau217) ratios. The test provides clear answers with positive or negative results that reflect a high or low likelihood of the presence of brain amyloid pathology.
Dr. Sebastian Palmqvist, Associate Professor of Neurology at Lund University and lead author of the article says, “The results of this study support the idea that a high-performing blood test has the potential to revolutionize the diagnostic work-up of Alzheimer’s disease in primary care. Primary care settings are where the vast majority of individuals with cognitive symptoms will be managed in the coming decades as secondary and tertiary healthcare providers do not have the resources to handle this patient volume.” He noted that additional studies of clinical utility are needed.
The study outcome meets the recommended performance criteria from the recent Global CEO Initiative on Alzheimer’s Disease (CEOi) blood biomarker working group, which developed an impactful guide to significantly elevate the quality of blood biomarker tests for patients with cognitive concerns.
Research Process, Findings and Implications
To compare diagnosis using clinical assessment alone to blood biomarker testing, the patients in the two prospective cohorts underwent standard primary care or secondary care (dementia specialists) clinical evaluation. Providers were then asked in a questionnaire if they thought their patient had Alzheimer’s disease. The blood test and the physicians’ estimation were compared to a clinical, biomarker-verified Alzheimer’s disease diagnosis.
Specifically, the researchers found that the PrecivityAD2 test output known as Amyloid Probability Score 2 demonstrated an accuracy at or above 90% for the total pooled cohort. Using a two cutoff-approach resulted in even higher accuracies and especially positive predictive values of 97-99% in patients with cognitive impairment, meaning that a positive blood test result really equals actual presence of AD pathology in the brain.
Dr. Joel Braunstein, C2N’s CEO and co-founder, says, “This landmark research shows how our consistent, robust, and high-performing blood tests are providing a clear picture of Alzheimer’s disease pathology. The test performed the same in primary care and specialty memory care, and it was highly accurate regardless of patients’ clinical presentation and medical comorbidities. The outcomes should eliminate the need for invasive lumbar punctures and costly amyloid PET scans for most patients while also helping to reduce the time to an accurate diagnosis on a global scale. Our full line of Precivity tests supplement the diagnostic work of healthcare providers in primary and secondary care settings. We’re all focused on reducing the delays in timely diagnosis and in the initiation of treatment for appropriate patients. This research highlights how blood tests can help in settings around the world.”
Dr. Braunstein pointed out that the availability of new amyloid lowering immunotherapies is anticipated to increase the number of patients seeking care for concerns about cognition and memory decline that may be associated with early-stage AD.
C2N has recently partnered with various leading global laboratories to increase access to the Precivity portfolio of blood tests, including Grupo Fleury in Brazil, Healius in Australia, Mediford in Japan (for research) and Mayo Clinic Laboratories (global). The company says additional global partnerships are expected soon.
The Precivity blood tests are intended for use in patients aged 55 and older with signs or symptoms of mild cognitive impairment or dementia who are undergoing evaluation of Alzheimer’s disease or dementia.
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. Over 30,000 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, Alzheimer’s Association and BrightFocus Foundation. For more information visit www.C2N.com.
Contacts
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