FDA Approves Elecsys pTau217 to Identify Alzheimer’s in Individuals 55 Years and Older

The U.S. Food and Drug Administration (FDA) has cleared the Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test, providing clinicians across primary and specialty care with a single blood-based option to aid in identifying amyloid pathology associated with Alzheimer’s disease in individuals 55 years and older with signs, symptoms or complaints of cognitive decline. 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.

According to a Roche news release, Elecsys pTau217 may help healthcare providers and health systems: 

• Support clinical decision-making across primary and speciality care settings through a single-biomarker blood test that provides positive, intermediate or negative amyloid pathology results to aid clinical assessment of amyloid pathology.
• Help identify appropriate next steps by distinguishing patients with a high or low likelihood of amyloid pathology and those who should be considered for further testing.
• Support a more efficient diagnostic pathway by providing a minimally invasive blood-based option that may help clinicians determine when additional evaluation, including PET imaging or CSF testing, is appropriate.