Roche Receives EU Approval for New Alzheimer’s Blood Test

Roche announced on May 12, 2026, that it has received the CE Mark, the European regulatory clearance required for sale in the region, for a new blood test designed for the early detection of Alzheimer’s disease pathology.

The test, known as Elecsys® plasma phosphorylated-tau 217 (pTau217), was developed in collaboration with Eli Lilly and Company. It is designed to measure the phosphorylated Tau (pTau) 217 protein, which serves as an indicator of amyloid pathology and is considered a hallmark of Alzheimer’s disease.

The Elecsys pTau217 test is the first blood test for Alzheimer’s disease pathology to utilize a single‑assay design, according to the company. This design is intended to both rule in and rule out amyloid pathology in individuals who present with symptoms or complaints of cognitive decline.

Diagnostic Capabilities and Comparison

The new test offers a different clinical utility compared to Roche’s previously approved pTau181 blood test. While the pTau181 test primarily assists in ruling out Alzheimer’s-related amyloid pathology, the pTau217 test can be used to both confirm and exclude the presence of the disease.

In terms of accuracy, the Elecsys pTau217 test maintains performance comparable to spinal fluid diagnostics when measured against the gold standard of PET-CT scans. Because it requires only a routine blood draw, it provides a minimally invasive and more convenient alternative to these traditional diagnostic methods.

The test is validated for use across both primary and secondary care settings. Roche stated that the same high and low cutoffs for the blood test can be applied in both primary and specialist care to determine the presence of amyloid pathology.

Addressing the Diagnostic Gap

The introduction of this blood test aims to address significant delays in dementia diagnosis. Roche reported that diagnosing dementia currently takes an average of 3.5 years, and an estimated 75% of people living with the condition remain undiagnosed.

Early detection of amyloid pathology is critical for the diagnosis and treatment of Alzheimer’s. Identifying the cause of cognitive symptoms early allows patients, families, and caregivers to access appropriate care and plan the next steps of treatment.

According to reporting from Reuters, the availability of blood tests could potentially speed up the diagnostic process and broaden access to existing treatments, such as Eli Lilly’s Kisunla and the treatment Leqembi, developed by Biogen and Eisai, as current diagnostic methods are often uncomfortable or costly.

Availability and Regulatory Status

Olivier Gillieron, the life cycle leader in cardiometabolic and neurology at Roche, told media in a call that the test is expected to become available in CE-marked markets starting in July 2026.

Beyond the European Union, the Elecsys pTau217 test has already been granted breakthrough device designation by the U.S. Food and Drug Administration (FDA).