FDA clears blood test for early Alzheimer's detection in symptomatic adults aged 40+

FDA-approved blood test enables earlier Alzheimer's detection for adults showing cognitive symptoms, potentially delaying disease progression.

The U.S. Food and Drug Administration has cleared C2N Diagnostics' PrecivityAD2 blood test for early Alzheimer's detection in individuals aged 40 and older who demonstrate cognitive symptoms. This test uses mass spectrometry to measure plasma Aβ42/40 and p-tau217/np-tau217 biomarkers. Clinical validation with 1,142 symptomatic adults achieved 97.6% accuracy for identifying positive Alzheimer's biomarkers. Crucially, the test remains consistent in patients with chronic kidney disease or diabetes, and requires cognitive symptoms to be present—meaning it is not intended for general population screening.

The test represents the first FDA-cleared blood-based solution for early Alzheimer's detection in this age group, avoiding the need for PET imaging or lumbar puncture. Developed by researchers at Washington University School of Medicine with co-leaders Randall J. Bateman and David M. Holtzman, it was commercialized through C2N Diagnostics, a WashU startup that acquired patented technologies from their labs.

This advancement could enable earlier intervention for the estimated 200,000 Americans with younger-onset Alzheimer's disease, potentially delaying progression. However, the test's accuracy metrics are based solely on symptomatic participants, and it remains restricted to individuals showing cognitive symptoms—meaning it does not address asymptomatic cases or the broader population. The U.S. Alzheimer's Association reports 7.4 million Americans aged 65+ have Alzheimer's, but this test targets a specific, symptomatic subgroup rather than the entire affected population.

Source: New Atlas