Roche receives CE Mark for Elecsys pTau181

Roche (RHHBY) announced it has received CE Mark for its Elecsys pTau181 test to measure phosphorylated Tau 181 protein which is an indicator of amyloid pathology, a hallmark of Alzheimer’s disease. The test, which has been developed in collaboration with Eli Lilly (LLY) and Company, can be used by clinicians in conjunction with other clinical information to rule out Alzheimer’s disease as the cause of cognitive decline. This could avoid the need for further confirmatory investigation for patients testing negative. The CE Mark for the Elecsys pTau181 blood test was based on data from a prospective, multicentre study, which included 787 patients across the US, 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% based on a 22.5% prevalence of amyloid positivity according to positron emission tomography scans, with 83.6% sensitivity. Roche is also developing the Elecsys pTau217 blood test, an in-vitro diagnostic immunoassay for the quantitative determination of the protein Phospho-Tau in human plasma for use as an aid in identifying amyloid pathology.