NEW YORK ─ Diadem on Monday announced it has obtained the CE mark for its AlzoSure Predict plasma-based biomarker test for the early prediction of Alzheimer's disease, enabling its marketing and use in the UK, EU, and other countries and regions that accept the designation.
Diadem's test uses an antibody that binds to U-p53AZ and its target sequences. U-p53AZ is a conformational variant of the p53 protein that has been implicated in the pathogenesis of Alzheimer's disease in multiple studies, the firm said.
The Brescia, Italy-based startup said the CE marking is supported by clinical data from a 482-patient longitudinal study showing that the test can identify whether individuals with early cognitive impairment will progress to full-fledged Alzheimer's disease up to six years before the illness is apparent.
"Earlier knowledge will benefit those who are found to be not likely to advance to [Alzheimer's disease] as well as those individuals found to be at risk who can now take steps to slow the progression of the condition," Diadem CEO Paul Kinnon said in a statement.
At the start of the study, patients were aged 50 or older and asymptomatic or at the early stages of Alzheimer's disease or other dementias.
The study results were published in a MedRxiv preprint and have been submitted to a peer-reviewed journal.
A second phase, which includes biobank data on more than 1,000 additional patients from Europe and the US, will be completed in the coming months, Diadem said.
The firm said it will partner with a variety of health providers to ensure wide access to its test and expects to make it available to physicians and patients in the EU in the coming months.
Diadem obtained US Food and Drug Administration breakthrough device designation for AlzoSure Predict in January.