FDA Clears Roche and Eli Lilly Alzheimer’s Blood Test for Ages 55+
Roche’s Elecsys pTau217 biomarker blood test, developed with Eli Lilly, received U.S. FDA clearance to help identify likely Alzheimer’s brain changes in adults aged 55+ with cognitive decline. Cleared after EU approval, it runs on more than 4,500 Roche analyzers in the U.S., and Labcorp and Quest plan to offer it through their networks to broaden access. Not a standalone diagnostic.
Coverage (6)
- FDA approves new blood test for Alzheimer’s disease (thehill.com)
- Alzheimer’s blood test developed by Roche, Lilly gets FDA clearance (insideindianabusiness.com)
- Roche, Eli Lilly's Alzheimer's blood test gets FDA clearance (reuters.com)
- Roche, Eli Lilly’s Alzheimer’s blood test gets U.S. FDA clearance (bnnbloomberg.ca)
- FDA Clears New Alzheimer’s Blood Test (forbes.com)
- Labcorp to Offer First FDA-Cleared Blood Test to Detect Alzheimer's Disease Pathology in Both Primary and Specialty Care Settings (prnewswire.com)