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FDA Clears Blood Test to Help Rule Out Alzheimer’s Disease in People Showing Symptoms
Roche's Elecsys pTau181 test helps primary care doctors rule out Alzheimer's with 97.9% accuracy, improving early diagnosis and guiding specialist referrals.
- On Monday, the U.S. Food and Drug Administration cleared Roche's Elecsys pTau181 test for primary-care use to aid initial assessment of Alzheimer's and cognitive decline.
- Earlier this year the Alzheimer's Association backed blood tests with at least 90% sensitivity and 75% specificity, and the availability of monoclonal antibodies such as lecanemab increased early diagnosis demand.
- The Elecsys pTau181 test measures plasma phosphorylated tau 181 and showed a 97.9% negative predictive value in ruling out Alzheimer's pathology among 312 participants.
- Brad Moore of Roche Diagnostics said integrating blood-based testing into primary care can speed answers and improve referrals, helping patients with cognitive symptoms and preserving neurologists' resources.
- Experts caution that one marker is insufficient and recommend panels and follow-up to stage disease accurately, noting patients with positive results need confirmatory amyloid testing.
36 Articles
36 Articles
By Jacqueline Howard, CNN The US Food and Drug Administration (FDA) has given the green light to another blood test to help evaluate Alzheimer's disease and other causes of cognitive decline, providing a broader understanding of when the disease can be ruled out. Roche Diagnostics said Monday that its Elecsys pTau181 test, developed in collaboration with Eli Lilly, could be used by primary care physicians to help identify patients who likely do …
By Jacqueline Howard, CNN The US Food and Drug Administration (FDA) has given the green light to another blood test to help evaluate Alzheimer's disease and other causes of cognitive decline, providing a broader understanding of when the disease can be ruled out. Roche Diagnostics said Monday that its Elecsys pTau181 test, developed in collaboration with Eli Lilly, could be used by primary care physicians to help identify patients who likely do …
FDA clears blood test to help rule out Alzheimer’s disease in people showing symptoms
The US Food and Drug Administration has given clearance to another blood test to help assess Alzheimer’s disease and other causes of cognitive decline, providing a broader understanding of when the disease can be ruled out.
Alzheimer's Blood Test Cleared for Primary Care Use
(MedPage Today) -- FDA cleared the Elecsys pTau181 test as the first blood-based biomarker to aid in the initial assessment of Alzheimer's disease and other causes of cognitive decline that can be used in the primary care setting, Roche announced...
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