FDA Clears Alzheimer’s Blood Test for Symptomatic Adults 40 and Older
PrecivityAD2 may help estimate amyloid pathology during a clinical evaluation, but it is neither general screening nor a stand-alone Alzheimer’s diagnosis.
The 60-second version
The FDA cleared PrecivityAD2 to help evaluate symptomatic adults age 40 and older, not to screen the general population.
Key points
- The test uses blood biomarkers to estimate amyloid pathology.
- Results must be interpreted within a broader clinical evaluation.
- A positive or abnormal result is not a stand-alone Alzheimer’s diagnosis and does not by itself justify treatment.
- The reported 1,142-subject study count is attributed to Clinical Trial Vanguard because performance values were not provided here.
- ADDF’s contextual claims are disclosed alongside its financial interest as an investor in C2N.
Verdict. The clearance broadens access to a diagnostic aid, but its value depends on selecting appropriate symptomatic patients and interpreting results clinically.
The FDA has cleared C2N Diagnostics’ PrecivityAD2 for adults age 40 and older who have signs or symptoms of cognitive impairment and are being evaluated for Alzheimer’s disease or another cause of cognitive decline. The clearance does not authorize population-wide screening, establish a diagnosis by itself, or show that treatment should begin.
ScopeWho the clearance covers
InterpretationWhat the test contributes
| What it measures | Blood biomarkers used to estimate whether amyloid pathology is present. |
|---|---|
| Intended setting | A clinical evaluation of a symptomatic adult age 40 or older. |
| What it can support | A clinician’s assessment of Alzheimer’s disease or other possible causes of cognitive decline. |
| What it cannot establish | A stand-alone diagnosis, a reason to start treatment, or a recommendation to screen healthy adults. |
| Possible next step | Clinical interpretation and, when appropriate, follow-up evaluation or testing. |