The FDA cleared PrecivityAD2, a blood test that assesses Alzheimer's-related brain changes, for adults age 40 and older with cognitive symptoms. Memory-clinic patients avoid overreading the headline by treating the result as specialist guidance, not a diagnosis by itself. PrecivityAD2 measures blood signals linked to amyloid pathology and sorts patients into negative, likely positive, or positive groups. According to the C2N Diagnostics announcement, FDA clearance came on August 19-20, 2026 under 510(k) K253240.
Medical information disclaimer: This article is for general educational purposes only and does not provide medical advice, diagnosis, or treatment. Always consult a physician or other qualified health professional about symptoms, medications, tests, or treatment decisions.
Official resources:
- Read the official guidance from C2N — Use this primary source to verify the official guidance.
- Read the official guidance from Healio — Use this primary source to verify the official guidance.
Table of Contents
- Who the test is for
- What the test measures
- Why the middle result matters most
- What to ask at your memory-clinic visit
Who the test is for
The clearance covers adults aged 40 and older with signs or symptoms of cognitive impairment. These patients are being evaluated for Alzheimer's disease or other cognitive decline. According to the NeurologyLive report, it is the first cleared test down to age 40.
It is not a screening test for people without symptoms. It is also not a stand-alone diagnosis. FDA documentation says it must be used with clinical assessment by professionals experienced in cognitive-impairment evaluation.
What the test measures
The test uses immunoprecipitation plus LC-MS/MS to measure plasma Aβ42/40 and p-tau217/non-p-tau217. Those two ratios combine into an Amyloid Probability Score 2. The score result is negative, likely positive, or positive.
Think of the ratios as chemical clues about amyloid-related processes. The score groups how likely amyloid pathology is present. A clinician then places that likelihood beside history, exams, and cognitive testing.
Why the middle result matters most
In a 1,142-person symptomatic validation cohort, results were compared with amyloid PET or spinal-fluid testing. Overall results showed 97.6% positive predictive value and 93.1% negative predictive value. Those headline numbers look very strong.
The intermediate "likely positive" group tells a different story. It occurred in 17.3% of that cohort and carried only 77.3% positive predictive value. That means many middle results need added testing, such as PET, spinal-fluid analysis, or close follow-up.
What to ask at your memory-clinic visit
Alzheimer's Association 2025 guidance says blood-biomarker tests must follow comprehensive clinical evaluation. According to the Alzheimer's Association guidance reported by Healio, results should be interpreted only in clinical context, not as the sole diagnosis.
Bring a symptom timeline, medications, sleep and mood changes, and a family observer when possible. Also confirm which test version you receive. C2N said the FDA-cleared kit version was expected later in 2026 while its CLIA-lab PrecivityAD2 remained available.
- Ask whether symptoms qualify you under the cleared use
- Ask which result category you received and what it suggests
- Ask what follow-up test or referral is recommended
- Ask whether you had the CLIA-lab test or the FDA-cleared kit, and what changes for your care plan
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