Diadem has reported that a study has confirmed that its blood-based test was able to accurately predict progression to Alzheimer’s disease years before diagnosis.
The company’s AlzoSure Predict prognostic biomarker test uses a proprietary antibody U-p53AZ to determine blood levels of an unfolded conformational variant of the p53 protein.
This p53 protein is known to trigger the pathogenesis of Alzheimer’s disease.
The results of the retrospective longitudinal study of the AlzoSure Predict confirmed that the test can accurately identify individuals who will advance to fully symptomatic Alzheimer’s disease up to six years before the symptoms become prominent.
In the study, the test achieved high accuracy levels with AUC values of around 99%.
The data from the study also indicates that AlzoSure Predict can differentiate between patients at different stages of cognitive decline, from asymptomatic to full Alzheimer’s disease dementia.
The study is now available as a medRxiv preprint and will be submitted to the Journal of Neuroscience.
Diadem CEO Paul Kinnon said: “The new data reinforce and validate our prior studies showing that AlzoSure Predict can identify individuals who will progress to Alzheimer’s dementia years before symptoms are evident, and it does so more accurately than established diagnostic tools such as PET imaging of amyloid b load.
“Best of all, our biomarker test is blood-based, simple, and affordable, making it accessible for a variety of applications, including broad-based patient screening.
“We aim to complete additional validation studies in the coming months and are targeting a global launch in collaboration with strategic partners next year.”
Globally, around 50 million people are suffering from dementia. Alzheimer’s disease accounts for nearly 60-70% of these cases.
Currently, there is no treatment for Alzheimer’s and its diagnosis is often slow and inconclusive.
In June, a team of researchers led by the Hong Kong University of Science and Technology (HKUST) developed a blood test to detect and screen Alzheimer’s disease early.