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 Roche's Elecsys blood test, which 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 and spinal taps are prohibitively expensive and restricted to specialized medical centers.
- The test is designed for anyone over 55 with signs of cognitive decline, and Roche states results are designed to be used "in conjunction with clinical information and other relevant findings" to help diagnose or rule out Alzheimer disease.
- 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."
- Manisha Parulekar notes the Elecsys test is not a screening tool for healthy individuals; a definitive Alzheimer diagnosis will always incorporate a doctor's evaluation of the patient's actual, observable symptoms alongside lab results.
29 Articles
29 Articles
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.
Could Roche and Lilly’s Blood Test Make Alzheimer’s Assessment More Accessible?
Testing for Alzheimer's-related brain changes has traditionally depended on procedures that can be expensive, invasive, or difficult to access. Roche Holding AG and Eli Lilly and Company (NYSE:LLY) may now have a simpler way to help physicians evaluate certain patients. The FDA has cleared Elecsys…
FDA approves innovative blood test with underlying technology for early diagnosis of Alzheimer's disease The article FDA: Approves blood test that helps in early assessment of Alzheimer's disease appeared first on Documento.
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