Roche and Eli Lilly’s Elecsys pTau217 blood test received U.S. FDA clearance on August 24, 2026.
The test is intended for people aged 55 and older who have signs, symptoms, or complaints of cognitive decline. It measures phosphorylated tau 217, a biomarker associated with Alzheimer’s-related amyloid pathology.
Results categorize patients as likely positive, likely negative, or intermediate for amyloid pathology, helping clinicians decide whether further evaluation may be needed.
The test is not a standalone diagnosis. Doctors are expected to interpret it alongside symptoms, medical history, and other clinical information.
It can run on more than 4,500 Roche laboratory analyzers already installed in the United States. Quest Diagnostics and Labcorp said they plan to offer it through their networks.
The clearance follows European approval in May. Roche did not disclose pricing.
The news does not represent the first FDA-authorized Alzheimer’s blood test:
Fujirebio’s Lumipulse was cleared in 2025, while Roche and Lilly previously received clearance for a separate pTau181 test aimed particularly at ruling out Alzheimer’s-related pathology in primary care.
Sources:
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