The FDA cleared PrecivityAD2, a blood test from C2N Diagnostics, on August 20, 2026, to help diagnose Alzheimer's disease in adults 40 and older who already have cognitive symptoms. It is the third blood-based Alzheimer's biomarker test the agency has cleared, and the first allowed for patients as young as 40 rather than only in older adults, according to the Alzheimer's Association. For someone with mild cognitive impairment (MCI) — a diagnosis that sits between normal aging and dementia — this clearance changes what a doctor can offer during a workup, but it does not settle what the test will cost or whether insurance will pay for it. The sections below walk through who qualifies, what the results mean, and what still has to be worked out before most patients can get the test paid for.
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 Alz — Use this primary source to verify the official guidance.
- Read the original report from Neurologylive — Use this primary source to review the complete report.
Table of Contents
- What the FDA actually cleared
- How accurate is the test, and does it matter for MCI specifically?
- When will it actually be available, and does your doctor need to order something new?
- Will insurance pay for it, and what will it cost out of pocket?
- What to ask your doctor if you or a family member has MCI
- Frequently Asked Questions
What the FDA actually cleared
The FDA's 510(k) clearance covers PrecivityAD2 for adults 40 and older who already show signs or symptoms of cognitive impairment and are being evaluated for Alzheimer's disease, according to the Alzheimer's Association. The test measures two plasma ratios using high-resolution mass spectrometry: amyloid (Aβ42/40) and tau (p-tau217/np-tau217).
It reports results against amyloid-PET or spinal fluid (CSF) reference standards rather than issuing a diagnosis on its own, according to NeurologyLive. The FDA's label is explicit about the test's limits: it aids a clinician's evaluation of a symptomatic adult and is not a screening tool or a stand-alone diagnostic test, according to Patient Care Online. That means a positive or negative result still has to be read alongside a cognitive exam, medical history, and a clinician's judgment — it is a piece of the workup, not a replacement for one.
How accurate is the test, and does it matter for MCI specifically?
In the clearance study of 1,142 participants, a positive PrecivityAD2 result carried a 97.6% positive predictive value for underlying amyloid pathology, and a negative result carried a 93.1% negative predictive value, both measured against amyloid PET or CSF testing, according to Practical Neurology. In plain terms, a positive result is very likely to reflect real amyloid buildup, and a negative result is very likely to reflect its absence. The test's value for MCI patients specifically has separate support.
A study presented at the 2026 Alzheimer's Association International Conference followed 1,310 patients with MCI or dementia evaluated by 165 physicians. Diagnostic accuracy among primary care clinicians rose from 65% to 93% once they reviewed PrecivityAD2 results, according to AJMC. That gain matters because MCI is exactly the stage where it's hardest to tell whether memory or thinking changes are due to Alzheimer's pathology, another condition, or normal aging — and where a primary care doctor, not a specialist, often makes the first call.
When will it actually be available, and does your doctor need to order something new?
C2N has told reporters the newly FDA-cleared version of PrecivityAD2 is expected to reach the market later in 2026. Until then, the company's existing CLIA-validated version — which was never FDA-cleared but was still a legitimate lab test — remains available now through C2N's own clinical laboratory, according to Patient Care Online.
That distinction matters for anyone trying to get tested soon: the version your doctor can order today is not the exact version the FDA just cleared, though both come from C2N and measure the same markers. If you or a family member have MCI symptoms now, ask your neurologist or primary care physician whether they already order the current PrecivityAD2 through C2N's lab, since that pathway doesn't require waiting for the newly cleared version to launch.
Will insurance pay for it, and what will it cost out of pocket?
Coverage is still uneven. As of July 2026, the insurer Anthem began covering PrecivityAD2, and C2N has said it hopes other private and public payers follow — but broad Medicare coverage had not been confirmed as of this FDA clearance, according to the Las Vegas Sun. That leaves most patients in a position where coverage depends heavily on their specific plan.
Cost history offers a useful anchor. Before this clearance, the predecessor PrecivityAD test for patients 60 and older with MCI symptoms listed at roughly $1,250 out of pocket, with no routine insurance coverage, compared with roughly $5,000 for a brain amyloid PET scan — a scan Medicare covers only in limited circumstances, according to American Family Physician. A separate 2025 cost-effectiveness analysis from Health Technology Wales modeled that PrecivityAD2 would need to be priced around $290–$450 if used as an initial triage test, or $1,150–$1,950 if used to confirm a diagnosis, to match the value of standard care — a modeled benchmark, not C2N's actual list price, according to the Health Technology Wales report.
- Before ordering: ask your insurer directly whether PrecivityAD2 is covered under your specific plan, since Anthem's coverage does not extend automatically to other insurers.
- Ask your doctor's office for the current out-of-pocket price, since the newly cleared version's list price was not set as of this clearance.
- If cost is a barrier, ask whether a CSF test or amyloid PET scan is covered under your plan as an alternative, since PET coverage through Medicare is limited to specific circumstances.
What to ask your doctor if you or a family member has MCI
A blood test result is only useful if it changes what happens next, so the practical questions are less about the test itself and more about the plan around it.
- Does this result change the current diagnosis, or does it need to be confirmed with PET or CSF testing, given the FDA label's instruction that the test aids evaluation rather than standing alone?
- Is the version being ordered the FDA-cleared PrecivityAD2 or the earlier CLIA-validated version, since both are offered through C2N's lab but only one carries the new clearance?
- What does a positive or negative result mean for treatment options now available for early Alzheimer's disease?
- Will my insurer cover this specific test, and if not, what are the next-best options given PET scan access is limited under Medicare?
Frequently Asked Questions
Is PrecivityAD2 a stand-alone way to diagnose Alzheimer's disease?
No. The FDA label states it aids a clinician's evaluation of a symptomatic adult and is not a screening tool or stand-alone diagnostic test, according to Patient Care Online.
Can someone younger than 60 get this test?
Yes. The clearance covers adults 40 and older with cognitive symptoms, making it the first such blood test cleared starting at that age, according to the Alzheimer's Association.
Does Medicare cover PrecivityAD2?
Broad Medicare coverage had not been confirmed as of this clearance; Anthem began covering the test in July 2026, according to the Las Vegas Sun.
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