Peer-Reviewed Journal Publishes Analytical Validation Results for the PrecivityAD™ Blood Test, Which Can Help Clinicians Detect Alzheimer’s Disease
ST. LOUIS — C₂N Diagnostics, which offers the PrecivityAD™ blood test that can help detect if certain markers for Alzheimer’s disease are in the brain, now has its analytical validation results available for review. The study appears in Clinica Chimica Acta, the official peer-reviewed journal of the International Federation of Clinical Chemistry and Laboratory Medicine.
The article is titled “The PrecivityAD™ Test: Accurate and Reliable LC-MS/MS Assays for Quantifying Plasma Amyloid Beta 40 and 42 and Apolipoprotein E Proteotype for the Assessment of Brain Amyloidosis”; it states that the “analytical validation experiments document excellent precision, a wide linear range, low limit of detection, and independence from common interferents, including commonly used medications.”
Dr. Joel Braunstein, the CEO of C₂N Diagnostics, says, “This analytic validation study adds to the body of published data about the PrecivityAD™ test, including research that shows it to be an accurate indicator of Alzheimer’s disease pathology among people experiencing memory impairment. This newly presented research demonstrates that the PrecivityAD™ blood test is precise, sensitive, accurate, and linear over a wide analytical range, and suitable for use in the clinical laboratory.”
The PrecivityAD™ test identifies whether a patient is likely to have amyloid plaques in the brain. The test relies on precise and robust quantitation of the Amyloid Beta 42/40 ratio (Aβ 42/40) and detection of the Apolipoprotein E proteotype (equivalent to ApoE genotype) in blood samples, using C₂N’s proprietary mass spectrometry platform.
The latest work follows Molecular Neurodegeneration publishing a research paper that stated the PrecivityAD™ blood test “can accurately identify brain amyloid status based on a single blood sample” and that the test’s “excellent performance” for Alzheimer’s disease (AD) diagnosis allows for “improved medical decision making and management, streamlined AD clinical trial enrollment, and better identification of who may benefit from an AD specific therapy.”
C₂N has recently completed a clinical validation study to assess diagnostic accuracy with the use of these biomarkers and to determine appropriate cut points for interpretation; the company expects it to be published soon, among other important clinical investigations in progress.
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 clinician.
The test is available in 48 states, the District of Columbia, and Puerto Rico; the exceptions are Maryland and New York, which require individual state processes for CLIA labs.
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About C2N Diagnostics, LLC
C₂N Diagnostics’ vision is to bring Clarity Through Innovation™. It focuses its therapeutic discovery efforts around mechanism-based approaches to prevent or stop the progression of human neurological disorders. Diagnostic efforts revolve around bringing accurate, widely accessible, and cost-effective blood tests to the clinic for the betterment of patient care and brain health monitoring. Its lead commercial product, PrecivityAD™, is a mass spectrometry-based test that measures in blood multiple analytes including Aβ42, Aβ40, and apolipoprotein E isoforms. This test predicts brain amyloid plaques as determined by PET scan results and in 2019 it received a Breakthrough Device Designation from the U.S. Food and Drug Administration. For more information visit www.C2NDiagnostics.com.
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