FDA Clears the Elecsys pTau217 Blood Test to Aid in Alzheimer Disease Assessment

The Food and Drug Administration (FDA) granted 510(k) clearance to the Elecsys Phospho-Tau (217P) Plasma (pTau217) single-biomarker blood test (Roche Diagnostics, Indianapolis, IN), which is designed to aid in the assessment of amyloid pathology associated with Alzheimer disease (AD) in individuals aged 55 years and older with signs, symptoms, or complaints of cognitive decline.

The test, developed in collaboration with Eli Lilly and Company (Indianapolis, IN), provides positive, intermediate, or negative result categories to help clinicians assess the likelihood of amyloid pathology. Results are intended to be interpreted alongside clinical information and other findings as part of the AD diagnostic pathway.

Clinical Use and Implementation

• Elecsys pTau217 is intended to support both rule-in and rule-out assessment of amyloid pathology.
• Roche stated that the assay uses the same validated clinical cutoffs in primary and specialty care settings.
• The test is designed for use on Roche’s proprietary Cobas laboratory instruments.
• In a press release, Roche reported that the assay demonstrated high agreement with amyloid PET imaging in individuals aged 55 years and older with signs, symptoms, or complaints of cognitive decline associated with AD.
• The test is not intended to predict development of dementia or other neurologic conditions or to monitor response to therapy.

Roche stated that Elecsys pTau217 may help clinicians identify patients with high or low likelihood of amyloid pathology and determine when additional evaluation, such as PET imaging, cerebrospinal fluid testing, or specialist referral, may be appropriate.

For neurologists, the clearance may expand access to blood-based biomarker testing during the evaluation of symptomatic cognitive decline, particularly in settings where amyloid PET or cerebrospinal fluid testing is not readily available. The test may also help guide referral decisions and determine which patients should be considered for additional Alzheimer disease–focused diagnostic evaluation.

Source

Roche Diagnostics. Roche receives FDA clearance for Elecsys pTau217, advancing Alzheimer’s disease assessment across primary and specialty care. News release. August 24, 2026.