ST. LOUIS--(BUSINESS WIRE)--C2N Diagnostics, a leader in advanced brain health diagnostics, says new research posted in the online version of Annals of Clinical and Translational Neurology (and soon in print form) affirms the clinical utility of its PrecivityAD® blood test, which healthcare providers use to help diagnosis Alzheimer’s disease (AD). The findings are believed to represent the first prospective, published evidence that clinicians use novel blood biomarker testing in a way that improves patient care management.
The Quality Improvement and Clinical Utility PrecivityAD Clinician Survey (QUIP I, ClinicalTrials.gov Identifier: NCT05477056) was a prospective, single-arm cohort study among 366 patients evaluated by 43 neurologists and other cognitive specialists in 15 academic centers and group practice sites. The authors of the journal article, “A Blood Biomarker Test for Brain Amyloid Impacts the Clinical Evaluation of Cognitive Impairment,” outline that the findings may have added relevance as drugmakers introduce new AD therapies.
The PrecivityAD blood test’s Amyloid Probability Score (APS) represents the estimated likelihood from 0 (low likelihood) to 100 (high likelihood) that a patient will be amyloid positive on amyloid PET imaging based on his or her Aβ42/40 ratio, age and Apolipoprotein E proteotype (equivalent to ApoE genotype). A positive amyloid PET scan is consistent with presence of amyloid plaques and an Alzheimer's disease diagnosis. In the pioneering study, clinicians selected patients with signs and symptoms of cognitive impairment who were evaluated for Alzheimer’s disease and other causes of cognitive decline.
In addition, a 95% (347/366) concordance rate was noted between clinicians’ patient selection and the PrecivityAD test’s intended use criteria. In the final analysis, including the 347 patients (median age 75 years, 56% women), pre-specified test result categories incorporated 133 (38%) Low APS, 162 (47%) High APS and 52 (15%) Intermediate APS patients. Clinicians’ pre- and post-test AD diagnosis probability changed from 58% to 23% for Low APS patients and 71% to 89% in High APS patients (p<0.0001).
The clinicians reported Low APS patients to have a lower AD probability post-test and were less likely to manage these patients with AD drug therapy (a decrease of 46% (p<0.0001), consistent with ruling out AD. Clinicians reported High APS patients to have a higher AD probability post-test and were more likely to manage these patients with AD drug therapy, consistent with ruling in AD (anti-AD drug therapy increased by 57% in High APS patients (p<0.0001)).
A literature review by the authors has shown that the current misdiagnosis rates for Alzheimer’s disease range from 30–50%. While amyloid positron emission tomography (PET) scans and cerebrospinal fluid (CSF) biomarkers substantially reduce misdiagnosis rates, their use is limited in routine clinical care due to high costs, logistic complexities, and patient burden.
“These data address a major gap in the further use of blood biomarkers in the real world, patient care setting. The CTAD 2022 Task Force Report and recent Alzheimer’s Association-National Institute on Aging draft guidelines underscore the use of prospective data and use of pre-specified endpoints, both of which were utilized in the QUIP I study,” says Joel B. Braunstein, MD, CEO of C2N Diagnostics. “Furthermore, the clinical utility data on the change in clinical decision-making associated with the PrecivityAD blood test results complement the previously published work on clinical validity and test performance of the PrecivityAD blood test.”
The authors state that larger trials with longer follow-up are desired to further understand the effect of the PrecivityAD blood test results on changes in diagnostic and management strategies as well as patient outcomes.
The PrecivityAD blood test is intended for use in individuals experiencing memory and thinking issues. The test is only available through an order by a healthcare provider. The test is available in 49 states, the District of Columbia, and Puerto Rico.
About C2N Diagnostics, LLC
C2N Diagnostics is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C2N strives to provide exceptional laboratory services and products 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’s 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.
