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FDA approves new Alzheimer’s blood test that your primary care doctor can order
The test can help primary care doctors identify patients likely to have Alzheimer’s-related brain changes without relying on invasive scans or spinal taps.
- The Food and Drug Administration approved Elecsys, a blood test from Roche that helps clinicians rule in or out amyloid plaques, the hallmarks of Alzheimer disease.
- Currently, many patients face prolonged uncertainty because traditional dementia diagnostics like brain scans are prohibitively expensive and restricted to specialized medical centers. Manisha Parulekar of Hackensack Meridian Health says blood biomarkers offer a "transformative alternative."
- The test is designed for anyone over the age of 55 with signs or complaints of cognitive decline. Roche states results are designed to be used "in conjunction with clinical information and other relevant findings" to help diagnose or rule out Alzheimer.
- Clifford Segil, a neurologist at Providence Saint John's Health Center in Santa Monica, California, expressed concerns about primary care doctors ordering this test, stating "Primary care doctors who obtain this test will not know how to counsel patients on the meaning of a positive or negative result."
- A definitive Alzheimer diagnosis will always incorporate a doctor's evaluation of the patient's actual, observable symptoms alongside the lab results. Manisha Parulekar notes the Elecsys test is not a screening tool for healthy individuals.
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FDA clears blood test for Alzheimer disease
The U.S. Food and Drug Administration has cleared the PrecivityAD2 test for adults 40 and older presenting with signs or symptoms of cognitive impairment and undergoing evaluation for Alzheimer's disease or other forms of cognitive decline.
·Douglas, United Kingdom
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