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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24 Articles
By Sandee LaMotte, CNN The U.S. Food and Drug Administration authorized Roche's blood test and partner Eli Lilly to help identify signs of Alzheimer's disease in people 55 years of age or older with cognitive impairment.The test, Elecsys pTau217, is a blood test from biomarkers that The post The blood test for Roche's Alzheimer's and Eli Lilly's is licensed by the FDA appeared first on KVIA.
FDA Clears pTau217 Blood Test for Early Alzheimer's Detection in Adults 40+
The Food and Drug Administration has cleared a new blood test that can help doctors identify adults as young as 40 who may be in the early stages of Alzheimer’s disease. Developed by ALZpath, the pTau217 assay measures levels of a specific protein fragment in the blood that rises when amyloid and tau proteins begin to accumulate in the brain. This approval marks a significant step toward making Alzheimer’s diagnostics more accessible, less invas…
FDA-Cleared Alzheimer’s Blood Test Marks a Shift Toward Earlier, Less Invasive Diagnosis
The Alzheimer’s diagnostic pathway is changing quickly. For many years, a definitive biological workup has depended on specialist access to amyloid PET imaging or cerebrospinal fluid testing, tools that are informative, but costly, invasive, and difficult to scale. That bottleneck has become more urgent as disease-modifying therapies enter clinical practice and require earlier, more accurate identification of patients with Alzheimer’s pathology.…
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