ST. LOUIS--(BUSINESS WIRE)-- New research finds that C₂N Diagnostics, LLC’s proprietary algorithm used in its PrecivityAD2 blood test, which is used by healthcare providers to determine Alzheimer’s disease (AD) pathology in individuals with early cognitive impairment, can identify brain amyloid status with “sensitivity, specificity, positive and negative predictive values that approximate those of amyloid positron emission tomography (PET) imaging.”

C₂N Diagnostics believes the findings in “Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association” are significant as the healthcare sector needs a PET scan alternative that’s widely accessible, accurate and cost-effective that can aid in the differential diagnosis of AD and AD-related dementias.

The AUC-ROC for the PrecivityAD2 test output, the Amyloid Probability Score 2 (APS2), was 0.94, yielding 88% agreement with brain amyloid status based on a single cut-off value. Diagnostic performance of the APS2 was similar by ethnicity, sex, age and apoE4 status. The APS2 result was the most robust method among the individual plasma amyloid and tau analytes measured to identify disease.

The research findings also showed that the AUC-ROC for the %p-tau217 (0.94), one of the core components of the APS2 algorithm, was superior to that for the p-tau217 concentration (0.91) for identifying brain amyloidosis. The researchers define %p-tau217 as the percentage of p-tau217 relative to np-tau217. These data showing the superiority of %p-tau217 over p-tau217 alone reaffirm the findings of another ground-breaking study recently published involving C₂N’s technology to identify amyloid pathology in pre-clinical AD with high accuracy comparable to amyloid PET.

Data Give Healthcare Providers Assurance as Patients Want Answers

In the published study, the PrecivityAD2 blood test was clinically validated in 583 individuals with cognitive impairment across two independent cohorts. The robustness of the findings was enhanced by the fact that one of the study cohorts, PARIS, included a prospective, difficult-to-diagnose, real-world population of U.S. Medicare beneficiaries presenting with memory concerns to clinics as part of a substudy of IDEAS¹.

The PrecivityAD2 blood test determines a patient’s likelihood (positive or negative) for the presence of amyloid plaques in the brain, one of the brain pathology findings of Alzheimer’s disease. In addition to helping healthcare providers determine Alzheimer’s disease pathology, the PrecivityAD2 test aids in medical management and treatment decisions.

Dr. Joel Braunstein, C₂N’s CEO says, “This latest research adds to the growing body of data that affirms the PrecivityAD2 test’s outstanding diagnostic performance and builds further confidence in the healthcare sector. The PrecivityAD2 blood test provides a less costly, more accessible and vitally needed option for healthcare providers who must conduct diagnostic testing for their patients facing memory and dementia care issues. We’re excited that additional studies are underway throughout the world that are seeking to further demonstrate the robust clinical performance and generalizability of the APS2 model.”

Dr. Braunstein and others note the PrecivityAD2 test’s appeal because of PET’s limitations for screening large number of patients as new disease-modifying drugs that can specifically treat the underlying causes of AD become available. These limitations include: PET’s cost for research use (currently estimated at around $6,500); that it exposes patients to radiation; and that it’s not easily accessible outside of large cities.

The PrecivityAD2 blood test is 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. Only a healthcare provider can order the PrecivityAD2 test.

The test is available in 49 states, the District of Columbia and Puerto Rico; the exception is New York, which requires an individual state process for CLIA labs. C₂N is working toward obtaining the requisite certification that will permit the PrecivityAD2 test to be available in New York in the near future.

Healthcare providers interested in ordering the PrecivityAD2 test can call 1.877.C2N.DIAG (226.3424) or visit https://precivityad.com.

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 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.

¹ www.ideas-study.org/Original-Study; ClinicalTrials.gov Identifier: NCT02420756.

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