C2N’s New Blood Test Combining p-tau217 Ratio with Aβ42/40 Ratio Points to Accuracy Levels Comparable to Existing Standards of Care for Amyloid Diagnosis in the Evaluation of Patients with Cognitive Impairment

SAN DIEGO–()–Data released from C2N Diagnostics, presented today at the Alzheimer’s Association International Conference, demonstrated that a blood test combining the Aβ42/40 ratio, a component of C2N’s commercially available PrecivityADTM blood test, with a unique p-tau217 ratio leads to testing performance that points to accuracy comparable to more complex amyloid PET imaging and invasive cerebrospinal fluid tests in identifying Alzheimer’s brain pathology.

The study, based on a difficult-to-diagnose population of 221 individuals dealing with cognitive impairment of unclear etiology who were originally part of the IDEAS study, observed that adding C2N’s proprietary p-tau217 ratio measurement to its existing Aβ42/40 ratio measurement greatly facilitates the identification of patients with Alzheimer’s brain pathology, even at the earliest stages of disease accumulation. The integrated score derived from the p-tau217 ratio and Aβ42/40 ratio achieved an AUC performance of 0.96 and accuracy of 90% when compared with quantitative amyloid PET results.

C2N introduced the clinically validated PrecivityAD™ blood test over a year ago to help healthcare providers determine the presence or absence of amyloid plaques in the brain, a hallmark sign of Alzheimer’s disease.

Dr. Joel Braunstein, C₂N’s CEO, says, “This news is an exciting and impactful milestone for our company and the Alzheimer’s field, in general. It reflects a tireless effort from our extraordinary team at C2N to continue innovating for the ultimate benefit of patient welfare. We are committed to transforming the way in which patients around the world receive a timely and accurate diagnosis for their memory concerns. Proper diagnosis is the first step in a patient’s journey to receive the care they need for their brain health. The progress we are making with the development of a logistically simple, cost-effective, and widely accessible blood test that determines the presence or absence of Alzheimer’s brain pathology with similar levels of performance to more invasive testing standards brings us one step closer to realizing our ambitions.”

Blood Test Benefits to Patients

In comparison to a plasma test, amyloid PET imaging is costly, a difficult procedure to access, and exposes individuals who do not have Alzheimer’s disease to unnecessary radiation. Cerebrospinal fluid biomarkers require a spinal tap, which is a needle insertion into the lower part of the back.

The new C2N assay relies on high-resolution mass spectrometry to precisely measure from a single sample of blood multiple different proteins implicated in Alzheimer’s-related brain changes. These markers include the beta-amyloid 42 and 40 peptides, and different phosphorylated and nonphosphorylated forms of the tau protein, including forms with phosphorylation at the tau217 and tau181 sites. Combining the Aβ42/40 ratio with the p-tau217/non-ptau217 ratio into a single integrated score resulted in superior performance to identify the presence or absence of brain amyloid plaques.

In May, C₂N Diagnostics introduced its p-tau Multi-Analyte Assay for Research Use Only. The clinical results presented today reflect an evolution of progress with both that assay and C2N’s original PrecivityAD™ test. Dr. Braunstein says, “We look forward to sharing even further developments in the weeks and months ahead as we expand our menu of advanced clinical diagnostic services for the betterment of patient care.”

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 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. For more information visit www.C2N.com.

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