FDA Clears PrecivityAD2 Blood Test for Alzheimer’s, Expanding 90%-Accurate Screening
Updated
Updated · WashU Medicine · Aug 21
FDA Clears PrecivityAD2 Blood Test for Alzheimer’s, Expanding 90%-Accurate Screening
3 articles · Updated · WashU Medicine · Aug 21
Summary
PrecivityAD2 won FDA marketing clearance as a blood test to help identify brain amyloid plaques tied to Alzheimer’s disease in certain patients.
More than 90% accuracy in prior studies and performance comparable to spinal taps and brain scans helped support clearance, even for patients with mild cognitive symptoms.
A single blood draw is analyzed by high-resolution mass spectrometry, measuring amyloid beta 42/40 and tau217 biomarkers rather than using immunoassay methods.
FDA clearance lets C2N Diagnostics market the test more broadly to clinicians and health systems and could ease insurance coverage, improving affordability and access.
Earlier diagnosis matters because disease-slowing Alzheimer’s treatments are now available and work better when started sooner.
Can this FDA-cleared test finally shift Alzheimer's diagnosis from exclusive specialist clinics to everyday primary care?
Will hidden factors like kidney disease turn this breakthrough Alzheimer's blood test into a diagnostic trap?
Could a single blood draw accurately predict your risk of severe dementia years before it strikes?
PrecivityAD2 Blood Test: Transforming Alzheimer’s Diagnosis with 91% Accuracy and FDA Approval
Overview
The FDA’s clearance of the PrecivityAD2 blood test in August 2026 marks a major advance in Alzheimer’s diagnosis, allowing clinicians to use a highly accurate, minimally invasive test to identify patients who may benefit from new treatments. This breakthrough is powered by high-resolution mass spectrometry, which overcomes the limitations of traditional immunoassays and enables precise measurement of key biomarkers. The test’s APS2 algorithm integrates multiple biomarker ratios, making it robust even for patients with other health conditions. As a result, primary care doctors can now achieve specialist-level accuracy, expanding early detection and access to care, while also supporting drug development and research into related diseases.