FDA authorizes Roche and Eli Lilly blood test for Alzheimer's signs

The U.S. Food and Drug Administration (FDA) has authorized a new blood test, Elecsys pTau217, developed by Roche in collaboration with Eli Lilly, to help identify biological signs associated with Alzheimer's disease in adults aged 55 and older with cognitive impairment. The test measures the pTau217 protein biomarker, which predicts the accumulation of beta-amyloid plaques in the brain with high accuracy, offering a less invasive alternative to PET scans or lumbar punctures Source: Infobae.

How it works

Elecsys pTau217 is a quantitative immunoassay that classifies results as positive, intermediate, or negative, indicating the likelihood of amyloid pathology. It is not intended as a standalone diagnostic; results must be interpreted alongside clinical evaluation and medical history Source: Diario Libre. Roche emphasizes that the test is not authorized to predict future dementia or monitor treatment efficacy Source: Diario Libre.

Availability and impact

The test can be processed on more than 4,500 Roche cobas analyzers already installed in the U.S., and major lab networks Labcorp and Quest Diagnostics plan to offer it, potentially expanding access significantly Source: Excelsior. Roche has not yet disclosed pricing Source: Diario Libre.

Regulatory context

The FDA authorization follows European certification in May 2026 Source: Infobae. This is not the first Alzheimer's blood test authorized; in 2025, the FDA cleared Fujirebio's Lumipulse Source: Diario Libre. A 2026 study involving over 2,100 people found strong ability to differentiate amyloid pathology, though performance depends on cutoff points and patient characteristics Source: Diario Libre.