C₂N Diagnostics, a leader in advanced brain health diagnostics, announced today that the Journal of the American Medical Association Network Open, a peer-reviewed medical journal from the American Medical Association, has published the combined results from two independent studies for the PrecivityAD™ blood test, which aids healthcare providers in diagnosing Alzheimer’s disease. The test uses high-resolution mass spectrometry to precisely measure proteins in the blood that indicate the likelihood of amyloid plaques in the brain. These measurements are made from a single blood draw sample.

The PrecivityAD™ test calculates an Amyloid Probability Score (APS). In two separate studies involving 686 participants, the APS showed high concordance with amyloid PET status in the participants, with an area under the curve of 0.88 and overall accuracy of 81%. All individuals included in the two studies were experiencing early signs of cognitive impairment or dementia at the time of their evaluation.

Dr. Joel Braunstein, CEO of C₂N Diagnostics, says, “The publication of this manuscript is a seminal moment for our company and for the Alzheimer’s field, in general. This is the first time the clinical diagnostic results from our PrecivityAD™ blood test, as measured in our CAP accredited and CLIA certified lab facility, have been published under rigorous peer-review. We expect the publication to be an important resource for clinicians, researchers, policymakers and patients who seek to take a proactive approach to their own healthcare. The findings from the two studies included in the analysis suggest that the PrecivityAD™ blood test has robust clinical validity in detecting brain amyloidosis and can aid clinicians in the diagnosis of Alzheimer’s disease among patients with cognitive impairment. The data presented is vital to enhancing awareness and visibility of this breakthrough diagnostic tool.”

“This blood test answers a critical need for less costly and more accessible diagnostic testing in Alzheimer’s care and research,” says Dr. Howard Fillit, Co-Founder and Chief Science Officer of the Alzheimer’s Drug Discovery Foundation (ADDF), which provided funding to support the development of the PrecivityAD™ test as part of its biomarker research initiatives. “It is a game-changer for clinical diagnosis by putting the early and specific diagnosis of Alzheimer’s disease into the mainstream of physician practice — helping physicians to help their patients. It will also play an important role in clinical trials by making screening enrollment and the monitoring of drug effects more efficient and cost-effective.”

PrecivityAD™ Blood Test’s Amyloid Probability Score

The APS reflects the estimated likelihood, ranging from 0 (low likelihood) to 100 (high likelihood) that the patient will be amyloid positive on an amyloid PET scan. The APS is calculated based on the person’s Aβ42/40 ratio and apoE proteotype, both measured in the blood sample, and the person’s age. A positive amyloid PET scan is consistent with the presence of amyloid plaques and an Alzheimer's disease diagnosis.

The PrecivityAD™ blood test is for patients 60 years old and older who are experiencing cognitive impairment, such as memory decline or other cognitive issues related to mild cognitive impairment or dementia.

As stated in the paper, “While amyloid PET and CSF biomarker measures have improved diagnosis of AD, their broad-scale clinical implementation remains challenging because of their high cost, patient avoidance of invasive diagnostic procedures or radiation exposure, limited reimbursement, and restricted availability.” The PrecivityAD™ blood test has the potential to substantially enhance accessibility to a diagnostic tool that doctors can use to evaluate patients presenting with cognitive impairment.

The PrecivityAD™ blood test is available in 49 states, the District of Columbia, and Puerto Rico, It also carries a CE Mark from the European Union and a Breakthrough Device Designation with the U.S. Food and Drug Administration. The test is not yet currently available in New York State.

“Assessment of a Plasma Amyloid Probability Score to Estimate Amyloid Positron Emission Tomography Findings Among Adults With Cognitive Impairment” is available at https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2791438?resultClick=3.

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 biomarker services and products are intended 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. For more information visit www.C2N.com.

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