FDA clears fourth Alzheimer's blood test in 15 months, Roche's Elecsys pTau217

The Food and Drug Administration cleared Roche's Elecsys pTau217 blood test on Aug. 24, giving primary care and specialist clinicians a single blood draw to help assess amyloid buildup in people 55 and older with cognitive complaints. It is the fourth such blood test cleared since May 2025.

The Food and Drug Administration has cleared Roche's Elecsys Phospho-Tau (217P) Plasma test, known as Elecsys pTau217, for use in identifying amyloid pathology associated with Alzheimer's disease in people 55 and older who have signs, symptoms or complaints of cognitive decline, the company announced on August 24, 2026. Developed with Eli Lilly, the test is described by Roche as the first single-biomarker blood test cleared to both rule in and rule out amyloid pathology using the same cutoffs across both primary and specialty care settings. It returns one of three result categories: positive, intermediate or negative.

The clearance is the fourth for a blood-based Alzheimer's test since May 2025, when the FDA cleared Fujirebio's Lumipulse G pTau217/Beta-Amyloid 1-42 Plasma Ratio test as the first blood test permitted for aiding diagnosis of Alzheimer's-related amyloid pathology, according to the FDA's own announcement at the time. Roche's earlier Elecsys pTau181 test, cleared in October 2025 for primary care use to help rule out amyloid pathology, was among the tests that followed. The Hill, reporting the new clearance, counted it as the fourth in that string, a pace that health reporters and clinicians have been tracking as blood tests edge toward replacing costlier PET scans and invasive spinal taps in the initial workup for cognitive complaints.

None of the cleared tests diagnose Alzheimer's disease on their own. The FDA clearance means the test can be marketed to indicate the presence or absence of amyloid plaques, one biological marker associated with Alzheimer's, in patients already being evaluated for cognitive decline; a positive result does not confirm dementia, and an intermediate result requires confirmatory testing such as a PET scan or spinal fluid analysis. Clinicians and Alzheimer's organizations have said the tests are meant to be used alongside a full clinical evaluation, not in place of one, and are cleared only for use in patients who already show symptoms, not for screening healthy people without complaints.

Roche said the test will become available to laboratories in the coming months; the company has not published pricing or estimated patient volumes for the new clearance.