FDA approves new blood test for Alzheimer’s disease
The clearance could expand access to earlier diagnosis as Labcorp and Quest Diagnostics plan to offer the test and studies showed 97.6% positive predictive value.
- On Monday, the U.S. Food and Drug Administration cleared the Elecsys pTau217 blood test from Roche and Eli Lilly to identify Alzheimer's-related brain changes in adults aged 55 and older with cognitive decline.
- Previously, doctors relied on expensive, invasive PET scans or cerebrospinal fluid testing to detect Alzheimer's pathology, creating barriers for patients seeking early diagnosis of cognitive decline.
- Roche and Lilly stated the test is "minimally invasive" and operates alongside "existing laboratory workflows," meaning clinics will not need to purchase additional equipment.
- Both Labcorp and Quest Diagnostics plan to offer the test through their laboratory networks, potentially expanding access across the United States later this year.
- Early diagnosis allows patients to begin treatments when they are most effective, positioning this clearance within a broader landscape of Alzheimer's tests including C2N Diagnostics' PrecivityAD2 for adults as young as 40.
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64 Articles
A simple blood test could significantly facilitate the assessment of Alzheimer's disease. FDA has now released the test for easier marketing.
Can Blood Tests Detect Alzheimer’s Disease in Its Early Stages?
By Noah Fromson Alzheimer’s disease affects more than 7 million Americans, and that number is expected to nearly double by 2060. Despite the growing number of cases, many people with Alzheimer’s disease and related dementias remain undiagnosed or untreated. Diagnosing Alzheimer’s disease can be challenging, particularly in its early stages. Brain PET scans and spinal taps (lumbar punctures) remain the gold standard for detecting the biological m…
FDA approves blood test to help detect Alzheimer’s disease in people 55 and older
The test measures p-tau217, a biomarker linked to Alzheimer’s, and can return positive, intermediate or negative results to aid clinical evaluation.
FDA Clears Roche Blood Test to Help Evaluate Alzheimer’s in Adults 55 and Older
A newly cleared blood test that measures the Alzheimer’s-associated biomarker pTau217 will give primary care physicians and specialists another less-invasive tool for evaluating patients experiencing ... The post FDA Clears Roche Blood Test to Help Evaluate Alzheimer’s in Adults 55 and Older first appeared on [your]NEWS.
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