C2N Diagnostics has received a clinical-laboratory permit from the New York State Department of Health (via its Clinical Laboratory Evaluation Program, CLEP), allowing its blood-based Alzheimer’s disease tests—PrecivityAD and PrecivityAD2—to be offered to patients in New York. This clearance expands the availability of the tests to all 50 U.S. states.
According to C2N, the approvals come after rigorous review and reflect the company’s commitment to “highest levels of accuracy and reliability.” The tests are intended for adults showing signs of mild cognitive impairment or dementia who are under evaluation for Alzheimer’s disease. The blood assays detect the presence of amyloid-plaque pathology in the brain—a hallmark of Alzheimer’s—and aim to support diagnosis and guide subsequent medical decisions.
With this permit, clinicians and memory-care providers across New York now have a convenient, less-invasive and more accessible diagnostic alternative to conventional methods like PET imaging or lumbar-puncture cerebrospinal-fluid analysis. Patients tested via PrecivityAD or PrecivityAD2 may benefit from earlier detection, more timely treatment discussions, and better care-planning or eligibility for disease-modifying therapies and clinical trials.
The permit milestone also strengthens C2N’s position as a major provider of Alzheimer’s diagnostics in the United States, following its recent submission of the PrecivityAD2 assay for regulatory review by the U.S. Food and Drug Administration (FDA).
