The FDA cleared PrecivityAD2 on August 20, 2026 for adults age 40 and older with cognitive symptoms being evaluated for Alzheimer's. Memory-clinic patients can compare four FDA-cleared blood tests by age range, intended setting, and how results guide next steps. PrecivityAD2 is a blood test that measures Alzheimer's-linked proteins to estimate the likelihood of brain amyloid. According to C2N Diagnostics, it is meant only for symptomatic evaluation, not screening or stand-alone diagnosis, as described in the C2N Diagnostics announcement.
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 original report from Healio — Use this primary source to review the complete report.
Table of Contents
- Who can use PrecivityAD2
- What the test measures and reports
- How do four cleared tests compare
- What to ask at the memory clinic
Who can use PrecivityAD2
The cleared use is narrow. It covers adults 40 and older who already show signs of cognitive impairment and are being evaluated for Alzheimer's. According to Medical News Today, C2N states the test is not intended as screening or as a stand-alone diagnostic, as noted in the Medical News Today summary.
That limit shapes clinic decisions. A patient with memory concerns, a care partner's observations, and current medicines gives context for interpretation. A patient without symptoms does not fit this clearance.
What the test measures and reports
The test uses mass spectrometry to measure plasma Aβ42/40 and p-tau217/np-tau217. It combines both ratios into an Amyloid Probability Score 2.
Results are reported as negative, positive, or likely-positive. In a 1,142-person symptomatic group compared with amyloid PET or spinal-fluid testing, positive results matched amyloid in 97.6% of cases and negative results matched in 93.1%. About 17.3% of results were likely-positive, with 77.3% matching amyloid, according to NeurologyLive in the NeurologyLive report.
How do four cleared tests compare
Patients can compare options by age cutoff, test target, and clinic role. According to Being Patient, four FDA-cleared options were available as of November 2026, as listed in the Being Patient guide.
The Alzheimer's Association's July 2025 guidance sets performance bars for such tests. For triage use, a test needs at least 90% sensitivity and 75% specificity, with negative results helping rule out pathology and positive results confirmed by PET or spinal fluid. To replace PET or spinal fluid, it needs 90% on both measures.
- Lumipulse, cleared May 2025, for specialty use in adults 55 and older
- Elecsys pTau181, a phosphorylated-tau blood marker test
- PrecivityAD2, cleared Aug. 20, 2026, for symptomatic adults 40 and older
- Elecsys pTau217, cleared Aug. 24, 2026
What to ask at the memory clinic
A blood draw offers a less invasive, earlier triage step than amyloid PET or spinal-tap spinal-fluid testing. Those confirmatory methods remain the long-standing standards but are costly and often involve specialty-center waitlists and travel.
Bring a short list to the visit and ask how each option fits your case. Ask for the result category in writing and the planned follow-up date before you leave.
- Which cleared test does this clinic offer for my age and symptoms
- What will negative, positive, or uncertain results change next
- Will a positive blood result still need PET or spinal-fluid confirmation
- How will medicines, kidney function, or other conditions affect interpretation
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