DIAGNOSIS:

The PrecivityAD™ blood test accurately and reliably detected brain amyloid on a single blood sample. Intended for people with memory and thinking issues, the test was granted Breakthrough Device Designation by the FDA.

A peer-reviewed journal has published the first research paper to state that the PrecivityAD™ blood test “can accurately identify brain amyloid status based on a single blood sample.”

The research paper in Molecular Neurodegeneration adds 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 Diagnostics, the test’s developer, says that forthcoming published research will further increase understanding of the test’s analytical performance and clinical robustness.

Method

“This first publication in a peer-reviewed format is an important milestone and one we’re proud to achieve. We know there’s an urgent need for non-invasive and easily available diagnostic tools that identify Alzheimer’s pathology,” says Dr. Joel Braunstein, CEO of C2N Diagnostics and one of the paper’s authors.

“This study used a prototype version of the PrecivityAD™ blood test, and the testing sites sent us samples collected under varied conditions.

“Even with the heterogeneity of samples, we found the test reliably detected brain amyloid — this speaks to the test’s robustness.”

Is it available?

This is the first widely accessible blood test to help physicians diagnose Alzheimer’s disease. The U.S. Food & Drug Administration has granted the test a Breakthrough Device Designation and the test also achieved the CE Mark from the European Union (In Vitro Diagnostic Medical Devices Directive 98/79/EC).

C2N Diagnostics reports that its lab recently received zero deficiencies during an inspection of its CLIA practices (the Clinical Laboratory Improvement Acts of 1988). The U.S. Department of Health and Human Services’ Centers for Medicare & Medicaid Services manages CLIA certification.

The PrecivityAD™ test is intended for use in individuals experiencing memory and thinking issues. The test is only available through a clinician’s order.

The test is available in 47 states, the District of Columbia, and Puerto Rico. The exceptions are Maryland, Pennsylvania, and New York, which require individual state certification processes for CLIA labs. C2N Diagnostics is working toward obtaining the requisite certifications that will permit the PrecivityAD™ test to be available in these states in the near future.