FDA Cleared PrecivityAD2 Blood Test for Alzheimer's
The newly approved diagnostic tool offers a less invasive way to detect Alzheimer's biomarkers through a blood draw.
Updated on Sept. 24, 2026 in Alzheimer’s
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The FDA has officially cleared the PrecivityAD2 blood test, a new diagnostic tool designed to identify amyloid plaques associated with Alzheimer's disease. Developed by C2N Diagnostics, the test utilizes mass spectrometry to provide an alternative to more invasive spinal taps or PET scans.
Why it matters
By simplifying the diagnostic process, the test allows for earlier identification of Alzheimer's, which is critical for patients to access treatments when they are most effective. This development represents a shift toward more accessible diagnostic options for patients across the United States.
The test accurately classified Alzheimer's biomarkers across racial groups in a 2022 study, even though three of four individual markers showed performance variations. This follows data indicating that 21.3% of Black Americans aged 70 and older currently live with dementia.
The players
C2N Diagnostics
This biotechnology company focuses on developing advanced diagnostic tests for brain health.
Washington University School of Medicine
This institution is a leading academic medical center where the technology for the PrecivityAD2 test was initially created.
Randall J. Bateman
He is a co-founder of C2N Diagnostics and a noted researcher in the field of neurology.
David M. Holtzman
He is a co-founder of C2N Diagnostics and a prominent expert in Alzheimer's disease research.
The details
The PrecivityAD2 diagnostic process requires only a single blood draw to analyze amyloid-beta ratios and biomarkers using high-resolution mass spectrometry. The technology behind the test originated at the Washington University School of Medicine and was further developed and validated by C2N Diagnostics.
Timeline
C2N Diagnostics was co-founded in 2007.
A study evaluating biomarker performance across racial groups was conducted in 2022.
The FDA cleared the PrecivityAD2 test for marketing on September 24, 2026.
The Big Picture
This approval marks a successful translation of laboratory-based research from the Washington University School of Medicine into a clinically available diagnostic tool. The development of this test follows the institution's long-standing research into the specific biomarker performance variations across diverse patient populations.
Patients may now seek a less invasive alternative to spinal taps and PET scans to assist in an Alzheimer's diagnosis. This shift potentially allows individuals to receive an earlier clinical assessment, which is vital for initiating effective therapeutic interventions.
The takeaway
The move toward blood-based diagnostic tests reflects a significant effort to lower the barrier for memory care and neurological assessment. Patients should consult with their healthcare providers about whether this new blood-based test is appropriate for their specific diagnostic needs.
Further reading
For more information on the evolving landscape of diagnostic tools, visit the Alzheimer’s section.
Source note: This article includes information reported by St. Louis American.
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