Roche’s Blood Test Gains CE Mark for Ruling Out Alzheimer’s Disease

Roche has received CE Mark approval for its Elecsys pTau181 blood test, a minimally invasive diagnostic tool designed to help rule out Alzheimer’s disease. The test measures levels of phosphorylated Tau (pTau) 181, a biomarker linked to amyloid pathology, a core feature of Alzheimer’s.

Developed in collaboration with Eli Lilly, the test is intended to be used with other clinical data to assess cognitive decline, potentially reducing the need for further testing when results are negative. The multi-centre, prospective trial included 787 participants across Australia, Europe, and the U.S., demonstrating a negative predictive value of 93.8% and 83.6% sensitivity.

Validated in diverse patient groups aged 55–80, this is the first global diagnostic trial of its kind. Roche is also developing the pTau217 test for enhanced amyloid detection. This approval follows Roche’s May 2025 launch of the Elecsys PRO-C3 liver fibrosis test.

28-07-2025