On Aug. 20, 2026, the FDA cleared PrecivityAD2 to aid Alzheimer's disease diagnosis in adults age 40 and older with cognitive symptoms, according to the clearance announcement from C2N Diagnostics.
PrecivityAD2 is a clinician-ordered blood test, and mild cognitive impairment is noticeable memory or thinking change that does not block daily function. People with mild cognitive impairment can use a memory-clinic visit to ask who qualifies, what the score means, and what comes next. Clear questions help the clinician match the test to symptoms, other health issues, and follow-up options.
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 Biospace — Use this primary source to verify the official guidance.
Table of Contents
- Who is this test meant for?
- What does one blood draw measure?
- How well did it match PET or spinal-fluid results?
- What should you ask at an MCI visit?
Who is this test meant for?
The test is for adults with current cognitive symptoms who are being evaluated for Alzheimer's disease. That group includes people with mild cognitive impairment and people with other memory or thinking symptoms. FDA labeling directs use alongside clinical assessment by clinicians experienced in cognitive evaluation.
The age range matters for younger patients. PrecivityAD2 is indicated from age 40, while earlier clearances covered ages 55 and up, according to reporting by Medical News Today. It is not for screening people without symptoms and not a standalone diagnosis.
What does one blood draw measure?
One blood sample is tested with high-resolution mass spectrometry. The method measures amyloid-beta 42/40 and p-tau217/non-p-tau217 ratios. Those two ratios are combined into one number.
That number is called Amyloid Probability Score 2, from 0 to 100. A higher score means a higher likelihood of amyloid pathology linked to Alzheimer's disease. Ask your clinician where your result falls and what cutoff your clinic uses.
How well did it match PET or spinal-fluid results?
In a 1,142-person study in symptomatic patients, results were compared with amyloid PET visual read or spinal-fluid biomarkers, according to the validation summary from C2N Diagnostics. A Positive result had 97.6% positive predictive value. A Negative result had 93.1% negative predictive value. Scores can also fall in a middle group.
An intermediate "likely positive" result occurred in 17.3% of participants and had only 77.3% predictive value, according to reporting by Medical Xpress. That middle result often leads to a talk about follow-up PET or spinal-fluid testing. Ask what each category would change for you. A clear Positive or Negative may simplify next steps. A middle result needs a plan for repeat testing, referral, records, timing, and cost.
What should you ask at an MCI visit?
Bring symptoms, onset dates, medicines, sleep issues, mood changes, and kidney history. Ask whether a clinician-ordered blood test fits your case.
Ask whether it could replace referral for a PET scan or lumbar puncture. Use these prompts to guide the talk: Take notes on which follow-up test is preferred, where it is done, and how long results take. Bring your current medicine list and any kidney test results to that visit.
- Am I in the intended group: symptoms present, evaluation underway, specialist input available?
- What would a Positive, Negative, or intermediate result change for diagnosis, referrals, work, driving, and care planning?
- What confirmatory testing and treatment-eligibility workup follows each result?
- Could my medicines, kidney function, or other conditions affect interpretation or timing?
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