The third FDA-cleared Alzheimer's blood-biomarker test — a blood test for Alzheimer's proteins — is C2N's PrecivityAD2 for symptomatic adults 40 and older. C2N says FDA cleared it Aug. 20, 2026, and memory-clinic use requires a doctor's order, often out-of-pocket payment, and confirmatory follow-up.
The FDA notes the first two clearances were Fujirebio's Lumipulse ratio in May 2025, then Roche Elecsys pTau181 in Oct. 2025. The first test covered symptomatic adults 55 and older. PrecivityAD2 lowers the cleared age to 40 and frames the decisions below.
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 notice from FDA — Use this primary source to verify the official announcement.
- Read the official guidance from C2N — Use this primary source to verify the official guidance.
Table of Contents
- What does PrecivityAD2 measure?
- How well does it match PET or spinal fluid?
- How do you get it in a memory clinic?
- What will you pay?
- What should you ask after the result?
What does PrecivityAD2 measure?
NeurologyLive reports PrecivityAD2 uses high-resolution mass spectrometry to measure plasma Aβ42/40 plus percent p-tau217. Aβ42/40 is the ratio of two amyloid fragments in blood.
Percent p-tau217 is the share of tau with an Alzheimer's-linked change. NeurologyLive lists the result as an Amyloid Probability Score 2 of Negative, Positive, or intermediate Likely Positive. Treat the label as a signal to discuss, not a final diagnosis.
How well does it match PET or spinal fluid?
In 1,142 symptomatic adults described by NeurologyLive, Positive blood results showed 97.6% positive predictive value versus amyloid PET or spinal fluid. Negative blood results showed 93.1% negative predictive value in the same comparison.
About 17.3% received intermediate Likely Positive results with 77.3% predictive value, according to NeurologyLive in its Aug. 21 summary. That middle group carries more uncertainty than clear Positive or Negative results.
How do you get it in a memory clinic?
C2N Diagnostics says in its Aug. 20 announcement the test is for adults 40 and older with cognitive symptoms undergoing evaluation.
Memory-clinic access requires a physician order, according to MedTech Dive reporting. C2N said the FDA-cleared kit would be available later in 2026. Its lab-developed PrecivityAD2 stayed orderable through C2N and partners such as Quest's AD-Detect, MedTech Dive reported.
- Ask your memory-clinic doctor whether the test fits your evaluation.
- Confirm whether the order uses C2N directly or a partner like Quest's AD-Detect.
- Verify coverage and prior authorization before the blood draw.
What will you pay?
PrecivityAD patient FAQs state Precivity tests are not currently covered by private payers, Medicare or Medicaid. The FAQs add C2N offers payment plans and assistance, and there is no public FDA-kit price or national Medicare policy. Third-party tracking puts lab-developed prices around $277–$626.
HealthcareOnTime's tracker reports in its cost and coverage tracker Anthem began covering PrecivityAD2 on Oct. 1, 2026. The tracker notes coverage is for eligible members age 40 and older and is plan-specific, so verify eligibility and prior authorization.
What should you ask after the result?
C2N states PrecivityAD2 is only an aid to diagnosis alongside standard clinical workup. It is not for screening without symptoms and not alone for diagnosis or treatment selection.
The Alzheimer's Association's July 2025 guideline, described by Healio, uses lower-specificity blood results as triage. Negatives help rule out pathology, while positives and likely positives need PET or spinal-fluid confirmation, plus review of other conditions and trial options. Ask your clinic whether confirmation testing, comorbidity review, and trial referral fit your result.
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