Diadem Srl today announced CE-IVD certification for its AlzoSure Predict prognostic blood test for the early prediction of Alzheimer’s disease.
The CE-IVD (European Conformity In-Vitro Diagnostic Medical Devices) certification allows Diadem to take the AlzoSure Predict test to market in the United Kingdom and the 27 countries of the European Union (EU) for Alzheimer’s. It also enables market development across much of the rest of the world. AlzoSure Predict is a biomarker blood test that can identify whether individuals over the age of 50 with signs of cognitive impairment will or will not progress to Alzheimer’s disease up to six years before definitive symptoms are apparent.
The CE mark is a legal requirement for marketing medical devices in the EU. It provides quality assurance for AlzoSure Predict, validating that the test meets the essential requirements of the European In-Vitro Diagnostics Directive (98/79/EC). This accreditation follows the U.S. Food and Drug Administration’s awarding of a Breakthrough Device Designation to AlzoSure Predict in January.
AlzoSure Predict’s accreditation is supported by positive clinical data from a 482-patient longitudinal study showing that the test can identify whether individuals will or will not progress to full-fledged AD up to six years before the illness is apparent. Patients were aged 50 years or older at the start of the study and asymptomatic or at the early stages of AD or other dementias. Study results were published in a MedRxiv preprint and have been submitted to a peer-reviewed journal. The second phase of this study, which includes biobank data on more than 1,000 additional patients from Europe and the US, will be completed in the coming months.
“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,” says Paul Kinnon, CEO of Diadem. “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.”
Click here for more information on AlzoSure Predict.
Featured image: AlzoSure Predict blood-based prognostic test for Alzheimer’s disease. Photo: Diadem Srl