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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.
PrecivityAD2 uses high-resolution mass spectrometry to provide quantitative measurements of protein biomarkers. The test is intended to be used in conjunction with a clinical assessment and is not intended as a screening or standalone diagnostic test.
The clearance is based on a trial of 1,142 adults presenting with signs or symptoms of cognitive decline, which showed the test had comparable accuracy to cerebrospinal fluid tests and brain scans for detecting amyloid plaques across the spectrum of cognitive impairment. PrecivityAD2 showed a 97.6% positive predictive value (rule-in) for a positive result and a 93.1% negative predictive value (rule-out) for a negative result, based on established reference methods of amyloid positron emission tomography visual read or cerebrospinal fluid biomarker testing. Overall, a likely positive test result occurred in 17.3% of participants, with a positive predictive value of 77.3%.
“We believe the PrecivityAD2 test will play a vital health system role in the years ahead to help streamline and simplify the complex diagnostic pathway that many patients face when dealing with serious memory concerns,” Joel Braunstein, co-founder, CEO and president of C2N Diagnostics, said in a statement.
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FDA clears blood test for Alzheimer disease (2026, September 3)
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