FDA Cleared New Blood Test for Alzheimer’s Diagnosis
The newly approved PrecivityAD2 test offers an easier, less invasive way to identify Alzheimer’s disease in patients.
Updated on Sept. 24, 2026 in Alzheimer’s
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The FDA has cleared the PrecivityAD2 blood test, developed by C2N Diagnostics, to help clinicians identify amyloid plaques associated with Alzheimer’s disease. This diagnostic tool aims to provide a more accessible alternative to traditional PET scans or spinal taps for patients across the United States.
Why it matters
By providing a less invasive testing option, this development could lower barriers to early diagnosis, which is critical for patients to access treatment when it is most effective. Earlier identification is particularly important for communities experiencing higher rates of dementia, such as Black Americans aged 70 and older, who have a 21.3% prevalence rate.
A 2022 Washington University study evaluated blood test performance across racial groups, confirming the PrecivityAD test accurately classified patients despite finding that 3 of 4 biomarkers performed differently across races.
The players
C2N Diagnostics
A biotechnology company focused on developing diagnostic tools for brain health and neurodegenerative conditions like Alzheimer’s.
Randall J. Bateman
A co-founder of C2N Diagnostics and researcher at Washington University known for his work in biomarker discovery.
David M. Holtzman
A co-founder of C2N Diagnostics and neuroscientist who specializes in the role of amyloid and tau in Alzheimer’s pathology.
The details
The test utilizes high-resolution mass spectrometry to analyze amyloid-beta ratios and specific biomarkers linked to the disease. A single blood draw is all that is required for the analysis, bypassing the need for imaging or invasive spinal procedures. The technology, which originates from research at Washington University, identifies the signature buildup of amyloid plaques in the brain.
Timeline
2007: C2N Diagnostics was co-founded.
2022: A Washington University study evaluated racial performance of blood tests.
September 24, 2026: The FDA cleared the PrecivityAD2 test for marketing.
Health Landscape
This clearance represents a shift for the Washington University Alzheimer’s research program from experimental investigation to accessible clinical diagnostics. It advances the standard of care by moving toward simpler blood-based identification of amyloid markers over existing, more costly procedures.
If you have concerns about memory or cognitive changes, this test offers a new conversation starter to have with your doctor regarding diagnostic options. Because the test requires only a blood draw, it may be a more practical initial step compared to more complex procedures for identifying disease markers.
The takeaway
This FDA clearance provides an easier alternative to traditional invasive diagnostics for identifying brain amyloid plaque accumulation. If you are experiencing symptoms, consult your physician to determine if current blood-based screening options are appropriate for your care plan.
Further reading
For more on diagnostic developments, explore the latest research in the United States Alzheimer’s section.
Source note: This article includes information reported by St. Louis American.
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