On October 29, 2020, C₂N Diagnostics announced that its blood test, PrecivityAD™, for diagnosing Alzheimer’s disease correctly identified the level of brain amyloid plaque (as determined by quantitative amyloid PET scans) in 86% of the participants. The study included 686 participants older than 60 years of age with subjective cognitive impairment or dementia. In early 2019, the United States Food and Drug Administration (FDA) granted C₂N Diagnostics a Breakthrough Device Designation for the PrecivityAD™ test. The PrecivityAD™ test has been validated in multiple states pursuant to Clinical Laboratory Improvement Amendments (CLIA) regulations and is used for clinical . . .
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