Roche has announced that Elecsys® pTau217, a blood test developed in collaboration with Eli Lilly and designed to both rule in and rule out Alzheimer’s pathology in people experiencing cognitive symptoms, has received a Conformité Européenne (CE) mark, for the European Economic Area (EEA). CE marks signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements.
Earlier in the week, Fujirebio Europe N.V. obtained a CE certificate of the Lumipulse G pTau 217 Plasma assay, also a blood test designed to measure Tau phosphorylated at threonine 217 (pTau 217) in human plasma. The tests looks for a protein in the blood called p‑tau217, which is linked to changes in the brain seen in Alzheimer’s disease. By measuring this protein, doctors can get clues about whether someone may have underlying Alzheimer’s‑related changes
According to the European Medicines Agency, manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment.
The Elecsys® pTau217 test is a simple blood test that helps doctors understand whether changes linked to Alzheimer’s disease are present in the brain. It can help both confirm when these changes are likely or rule them out when they are not. Because it only requires a routine blood sample, it’s easier and less invasive than other tests . The rule in and rule out blood test marks an important step forward in Alzheimer’s diagnosis with the potential to support faster, more accessible and less invasive routes to diagnosis across both everyday healthcare settings and specialist care. for millions of people worldwide.
In their announcement, Roche said:
“Elecsys® pTau217 is intended to both rule in and rule out amyloid pathology across primary and secondary care settings, using a blood draw as an alternative to more invasive or less accessible diagnostic approaches such as cerebrospinal fluid assessment or positron emission tomography (PET) scans.
The Elecsys® pTau217 CE Mark was granted based on data from retrospective studies of a real-world population at the earliest stages of Alzheimer’s (Subjective Cognitive Decline, Mild Cognitive Impairment and Mild Dementia), a point where individuals may notice memory changes but still live independently.”
Dementia diagnosis remains a major global challenge. An estimated 75% of people living with dementia remain undiagnosed, and those who do receive a diagnosis typically wait around 3.5 years after symptoms first appear. With tens of thousands of participants needed for active Alzheimer’s clinical trials (i.e. 55,000 participants are required to populate all currently active trials), health systems need scalable diagnostic pathways that can support earlier identification. Earlier, more accessible diagnostic tools could help reduce these delays, giving people and families answers sooner and enabling more timely access to care, support and planning.
The CE mark for Elecsys® pTau217 follows other recent advances in diagnostic testing, including previous regulatory progress for tests designed to rule out Alzheimer’s pathology- Fujirebio and Roche both received FDA clearance for ‘rule out’ tests, Roche Elecsys pTau181 also got the CE Mark for rule out last year.
This announcements comes at a moment when Alzheimer’s research is advancing rapidly, reinforcing Alzheimer’s Disease International call for governments and health systems to prioritise earlier diagnosis as a foundation for better care, support and future treatment access. The announcement also aligns with the theme of this year’s World Alzheimer’s Month campaign, which will focus on the importance of early diagnosis, and with this year’s World Alzheimer Report, which will focus on clinical trials.
As the global federation of Alzheimer’s and dementia associations, ADI continues to call for governments and health systems to invest in timely diagnosis, post-diagnostic support and equitable access to innovations in dementia care.