On 23 July, the biotechnology company Roche announced it has received CE Mark for its Elecsys pTau181 test to measure phosphorylated Tau (pTau) 181 protein which is an indicator of amyloid pathology, a hallmark of Alzheimer’s disease (AD). The test, which has been developed in collaboration with Eli Lilly and Company, can be used by clinicians in conjunction with other clinical information to rule out AD. Current methods to confirm amyloid pathology, including positron emission tomography (PET) and cerebrospinal fluid (CSF) assessment, can be expensive, difficult to access and invasive. With a negative Elecsys pTau181 blood test, people can avoid further unnecessary investigations for AD using CSF or PET and can identify the care pathway that is right for them.
Clinical study results support that the test can be implemented effectively across care settings, including primary care, where most patients first seek help for cognitive concerns. The CE mark was based on data from a prospective and multicentre study, which included 787 participants across the US, Europe and Australia. The study showed the test was able to rule out AD with a high negative predictive value of 93.8% based on a 22.5% prevalence of amyloid positivity according to PET scans, with 83.6% sensitivity.