C2N’s PrecivityAD® Blood Test, Which Identifies Amyloid Pathology as an Aid to Alzheimer’s Disease Diagnosis, Further Demonstrates Its High Accuracy in Newly Published Research

Study addresses the use of pre-specified cut-off values, one of the EU/US/Clinical Trials in Alzheimer's Disease (CTAD) Task Force key recommendations

C₂N Diagnostics today announced the Annals of Clinical and Translational Neurology has published online a new study that further demonstrates the Amyloid Probability Score (APS), used in the company’s PrecivityAD® blood test to help healthcare providers better diagnose Alzheimer’s Disease (AD), is a reliable marker of brain amyloidosis among individuals aged 60 years and older with cognitive impairment (current Intended Use population). The research also shows a person’s APS score is a potential indicator of individuals actively accumulating amyloid, a dynamic and evolving process characteristic of progressive AD pathology.

In addition, C₂N says this analysis provides confirmatory evidence that the previously established APS cutoff values have high diagnostic performance when used across different cohorts. In the Intended Use population for the PrecivityAD blood test, sensitivity for identifying amyloid presence by amyloid PET imaging was ~85% (95% confidence interval [CI] of ~73-92%) and specificity was 96% (95% CI of 81-99%) after excluding the ~14% of patients that fell into an intermediate APS group population for which the test is considered non-informative. The exploratory analyses demonstrated the APS model retained strong diagnostic performance even among healthy individuals. These findings support further studies to evaluate the PrecivityAD test as a future potential screening test in cognitively unimpaired individuals (high risk) for whom biomarker testing outside of the clinical research context might be warranted.

The company says the study helps to address one of the EU/US/Clinical Trials in Alzheimer's Disease (CTAD) Task Force key recommendations that prioritizes validation of established cut-off values using independent clinical datasets in the Intended Use population.

Researchers analyzed the diagnostic performance of the PrecivityAD blood test in a group of 200 Australian Imaging, Biomarker & Lifestyle Flagship Study of Ageing (AIBL) study participants, who were either cognitively impaired or healthy controls, and for whom a blood sample and amyloid PET imaging were available.

“Congratulations to the research team members for providing important findings that add to our field’s understanding of the potential role for using high performance blood biomarkers in routine clinical care for patients with cognitive impairment. This publication impressively brings the number of Precivity-related biomarker measures we have reported through peer-reviewed publications to approximately 10,000. A major unmet need exists for a non-invasive, convenient and easy-to-access method for evaluating patients for Alzheimer's Disease as a reliable alternative to cerebrospinal fluid (CSF) and amyloid PET,” said Dr. Joel Braunstein, C₂N’s CEO and a co-author of the publication. “The PrecivityAD blood test addresses this unmet need as a CLIA validated laboratory developed test available for use by healthcare providers to evaluate for the presence or absence of amyloid pathology in cognitively impaired individuals over 60 years of age.”

The Annals of Clinical and Translational Neurology published research is available at https://precivityad.com/publications.

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. 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.

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