Italy’s Diadem has secured the CE-IVD certification for its AlzoSure Predict prognostic blood test for the early prediction of Alzheimer’s disease (AD).
AlzoSure Predict is a non-invasive plasma-based biomarker test that is developed to identify whether people aged over 50 years with symptoms of cognitive impairment will have Alzheimer’s disease, up to 6 years before the onset of illness.
The European Conformity In-Vitro Diagnostic Medical Devices (CE IVD) certification will enable the firm to take AlzoSure to market in UK and Europe.
The certification is based on positive clinical data from a 482-patient longitudinal study that demonstrated the test’s ability to detect whether individuals will or will not progress to full-fledged AD.
Diadem is expected to complete the second phase of this study in the coming months. The study will consist of biobank data on more than 1,000 additional patients from Europe and the US.
Diadem chief executive officer Paul Kinnon said: “This first regulatory approval for AlzoSure Predict is a signal event for our scientists whose insight and commitment have enabled us to achieve this milestone,
“We believe it represents a significant advance for the millions of patients and their families in Europe at risk from Alzheimer’s disease. Earlier knowledge will benefit those who are found to be not likely to advance to AD as well as those individuals found to be at risk, who can now take steps to slow the progression of the condition.
“We will be partnering with a variety of health providers to ensure wide access to AlzoSure Predict and expect the test to be available to physicians and patients in the EU in the coming months.”
In January this year, the US Food and Drug Administration (FDA) awarded Breakthrough Device Designation to AlzoSure Predict.
