FDA Approves Alzheimer’s Blood Test Developed by Roche and Eli Lilly
The Elecsys Phospho-Tau Plasma test identifies amyloid pathology associated with Alzheimer’s
- The FDA cleared a blood test developed by Roche and Eli Lilly to identify Alzheimer’s disease symptoms.
- The Elecsys Phospho-Tau Plasma test identifies amyloid pathology associated with Alzheimer’s in people 55 years or older.
- Quest Diagnostics and Labcorp both announced plans to start offering the new blood test.
The Food and Drug Administration cleared a blood test for identifying Alzheimer’s disease symptoms, which was developed by Roche and Eli Lilly.
The Elecsys Phospho-Tau Plasma test identifies amyloid pathology associated with Alzheimer’s in people 55 years or older.
It provides positive, intermediate and negative result categories to support doctors assessing the likelihood of amyloid pathology. Results are interpreted in conjunction with clinical information and other relevant findings as part of an Alzheimer’s diagnosis.
The blood test is meant to address the gap in diagnoses, as an estimated 75% of people living with dementia are undiagnosed, Roche said.
Quest Diagnostics and Labcorp both said they plan to start offering the blood test.
Labcorp, a lab services company, said the test is an important tool for clinicians to rule in or rule out amyloid pathology in people showing signs of cognitive decline. For Quest, the test will be part of its menu of blood-based Alzheimer’s biomarker tests under the AD-Detect brand name.