September 2025—Roche has received the CE mark for its Elecsys pTau181 test to measure phosphorylated tau 181 protein, an indicator of amyloid pathology. The test, developed in collaboration with Eli Lilly, can be used by clinicians in conjunction with other clinical information to rule out Alzheimer’s disease as the cause of cognitive decline.
The CE mark for the test was based on data from a prospective, multicenter study that included 787 patients in the United States, Europe, and Australia. The study showed the test was able to rule out Alzheimer’s disease with a high negative predictive value of 93.8 percent, based on a 22.5 percent prevalence of amyloid positivity according to PET scans, and with 83.6 percent sensitivity.
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