The third FDA-cleared Alzheimer's blood biomarker test is C2N Diagnostics' PrecivityAD2, cleared Aug. 20, 2026. For family caregivers, it offers a doctor-ordered blood draw to help evaluate memory symptoms in a loved one. A blood biomarker test measures proteins in blood linked to Alzheimer's-related amyloid buildup in the brain.
The Alzheimer's Association reports it follows Fujirebio's Lumipulse in May 2025 and Roche's pTau181 in Oct. 2025 Alzheimer's Association announcement. It does not replace a doctor's judgment. It gives the doctor another tool during evaluation.
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 Washu — Use this primary source to verify the official guidance.
- Read the official guidance from Alz — Use this primary source to verify the official guidance.
Table of Contents
- Who can receive the test?
- What does the blood draw measure?
- How well did it perform?
- What should caregivers do next?
Who can receive the test?
The FDA decision summary states the test is indicated for adults age 40 and older. They must have signs or symptoms of cognitive impairment. They must be under evaluation for Alzheimer's or other cognitive decline.
AJMC reports it is the first cleared Alzheimer's blood test available to symptomatic adults as young as 40. Earlier cleared tests were limited to adults 55 and older. That change matters for early-onset concerns in middle age.
- Age 40 or older
- Has signs or symptoms of cognitive impairment
- Is being evaluated for Alzheimer's or other decline
What does the blood draw measure?
WashU Medicine reports the test uses high-resolution mass spectrometry WashU Medicine report. It measures plasma Aβ42/40 plus percent p-tau217. Both are blood markers tied to amyloid pathology.
The results are combined into an Amyloid Probability Score 2. The score runs from 0 to 100. The clinician reads the score with other clinical findings.
How well did it perform?
C2N Diagnostics reported validation in a 1,142-person symptomatic cohort C2N announcement shared via Business Wire. Amyloid PET or cerebrospinal fluid served as the reference. A positive result matched amyloid 97.6% of the time.
A negative result matched absence of amyloid 93.1% of the time. Those numbers describe agreement with PET or spinal fluid in that study. They do not mean the test alone can diagnose Alzheimer's.
What should caregivers do next?
The FDA decision summary states the test is prescription-only FDA decision summary. It is not intended as screening or as a stand-alone diagnostic. It is an aid alongside history, exam, cognitive testing, and sometimes imaging or spinal fluid.
AJMC reports the practical effect is a single blood draw ordered by a clinician experienced in cognitive impairment. It can replace an initial referral for lumbar puncture or PET. It can support earlier diagnosis, care planning, and timely treatment discussion.
- Write down observed memory, language, and daily-task changes with dates
- Ask a primary-care doctor or memory clinician if the blood test fits
- Bring medication lists and prior test results to the visit
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