Roche has received U.S. Food and Drug Administration (FDA) clearance for the Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test, according to an announcement.

Developed in collaboration with Eli Lilly and Company, Elecsys pTau217 is the first and only FDA-cleared, single-biomarker blood test that supports both rule-in and rule-out assessment of amyloid pathology using the same validated clinical cutoffs across primary and specialty care settings. 

The assay provides positive, intermediate and negative result categories to support assessment of the likelihood of amyloid pathology. Results are interpreted in conjunction with clinical information and other relevant findings as part of the Alzheimer’s disease diagnostic pathway.

Healthcare providers across primary and specialty care now have access to the test. It is designed for use across Roche’s more than 4,500 cobas laboratory instruments in the United States. 

Evaluated in individuals 55 years and older with signs, symptoms or complaints of cognitive decline associated with Alzheimer’s disease, Elecsys pTau217 demonstrated high agreement with amyloid PET imaging, providing clinicians with minimally invasive option for assessing amyloid pathology.

Elecsys pTau217 is not intended to be used as a stand-alone test. Results should be interpreted in conjunction with other diagnostic tools and clinical information. The safety and effectiveness of the assay have not been established for predicting development of dementia or other neurologic conditions or for monitoring the effect of therapeutic products.

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