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FDA Clears Blood Test to Help Rule Out Alzheimer's Disease in People Showing Symptoms
Roche's Elecsys pTau181 test offers primary care clinicians a 97.9% accuracy in ruling out Alzheimer's pathology to guide timely referrals and reduce specialist burden.
- Roche Diagnostics announced Monday that it received FDA clearance for the Elecsys pTau181 test to aid initial cognitive decline assessment in primary care, developed with Eli Lilly.
- Earlier this year, guidance from the Alzheimer's Association noted blood tests need 90% sensitivity and 75% specificity, and regulatory momentum grew after FDA cleared Fujirebio Diagnostics' Lumipulse test in May.
- The Elecsys pTau181 assay measures plasma pTau181, and in a study of 312 participants it ruled out Alzheimer's pathology with a 97.9% negative predictive value for adults 55 and older.
- Roche noted it has about 4,500 instruments installed in U.S. clinical laboratories and said blood testing could help identify candidates for amyloid-busting drugs, `By enabling use in primary care...` .
- Experts caution we must be cautious about mass adoption because of false positives, and about 92% of adults with mild cognitive impairment may go undiagnosed, Isaacson said.
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64 Articles
The Laconia Daily Sun+24 Reposted by 24 other sources
FDA Clears New Blood Test to Help Rule Out Alzheimer’s Disease
Key Takeaways
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 …
Coverage Details
Total News Sources64
Leaning Left7Leaning Right3Center33Last UpdatedBias Distribution77% Center
Bias Distribution
- 77% of the sources are Center
77% Center
L 16%
C 77%
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