Diadem Srl today announced CE IVD certification for its AlzoSure® Predict prognostic blood test for the early prediction of Alzheimer's disease (AD).
The CE IVD (European Conformity In-Vitro Diagnostic Medical Devices) certification allows Diadem to take the AlzoSure® Predict test to market in the UK and the 27 countries of the European Union (EU).
It also enables market development across much of the rest of the world. AlzoSure® Predict is a biomarker blood test that can identify with high accuracy 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," said 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."
AlzoSure® Predict is a non-invasive plasma-based biomarker test to accurately predict the probability that a patient aged over 50 years with cognitive impairment will progress to Alzheimer's dementia.
The company's technology uses an analytical method that includes a proprietary and patented antibody developed by Diadem designed to bind 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 AD in multiple studies.
About Alzheimer's Disease:
There are about 50 million people suffering from dementia worldwide. Alzheimer's disease is the most common form and accounts for 60-70% of cases. At present there are no disease modifying treatments for Alzheimer's, and therapies to treat symptoms are limited. There are about 10 million new cases per year, and the incidence is rising rapidly as the population ages.
The current total cost of care is enormous--estimated at $1 trillion in the U.S. annually and expected to double by 2030. Currently, diagnosis of Alzheimer's disease is slow, inconclusive, invasive and expensive. Development of effective therapies for Alzheimer's has been hindered by the lack of accurate and cost-effective prognostic and diagnostic methods.
For more information, visit www.diademdx.com
