FDA clears blood test for Alzheimer disease
The U.S. Food and Drug Administration has cleared the PrecivityAD2 test for adults 40 and older presenting with signs or symptoms of cognitive impairment and undergoing evaluation for Alzheimer's disease or other forms of cognitive decline.
The U.S. Food and Drug Administration (FDA) has approved a blood test called PrecivityAD2 for detecting Alzheimer's disease in adults aged 40 and older who are experiencing cognitive impairment. This test measures high-resolution protein biomarkers using mass spectrometry.
The FDA's approval is based on a trial involving 1,142 adults with signs or symptoms of cognitive decline. The test demonstrated comparable accuracy to existing methods like cerebrospinal fluid tests and brain scans for identifying amyloid plaques, which are indicative of Alzheimer's disease.
PrecivityAD2 achieved a 97.6% positive predictive value, meaning it correctly identified individuals with the disease when the test result was positive. It also had a 93.1% negative predictive value, meaning it accurately ruled out the disease when the test result was negative. Overall, approximately 17.3% of participants had a likely positive test result, with a positive predictive value of 77.3%.
Joel Braunstein, co-founder, CEO, and president of C2N Diagnostics, expressed optimism about the test's potential role in simplifying the diagnostic process for patients dealing with memory concerns. The FDA has cleared PrecivityAD2 to be used alongside clinical assessment, but it is not intended as a standalone screening or diagnostic tool.
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