Roche has obtained CE Mark approval for Elecsys pTau217, a blood test developed with Eli Lilly to detect amyloid pathology associated with Alzheimer’s disease, enabling early diagnosis across care settings.
Roche has been granted CE Mark for Elecsys pTau217, a blood test developed in collaboration with Eli Lilly and Company and designed to measure the phosphorylated Tau (pTau) 217 protein, an indicator of amyloid pathology and a hallmark of Alzheimer’s disease, according to an announcement.
The same cutoffs (high and low) of the blood test can be used across primary and secondary care settings, to rule in or rule out amyloid pathology in people presenting with symptoms or complaints of cognitive decline.
The pTau217 assay contributes to addressing the undiagnosed population, with reliable detection of AD pathology in individuals with early cognitive decline symptoms.
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.This focus ensures the test performs where it is needed most: at the dawn of the disease, when timely intervention has the greatest potential to preserve independence and slow the progression of decline.
