Diadem Receives CE-IVD Certification to Market Its AlzoSure® Predict Prognostic
Blood Test for the Early Prediction of Alzheimer’s Disease in Europe
—First Approved Blood Test that Can Predict Likely Progression to Alzheimer’s Disease Up to Six Years in Advance—
—Clinical Studies Show AlzoSure® Predict Can Identify Whether Individuals with Early Cognitive Impairment Will or Will Not Progress to Alzheimer’s Disease with High Accuracy—
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.
Clinicians click here and Patients/Families click here for more information on accessing AlzoSure® Predict.
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.
Diadem was founded as a spin-off of the University of Brescia (Italy) and funded by Panakes Partners. The company is developing the first blood-based prognostic test for the early detection of dementia, with a focus on Alzheimer’s disease. The lack of accurate, accessible and affordable diagnostic tools is a major contributor to the absence of effective treatments for this devastating condition. As a result, patients are not diagnosed until late in the illness, when effective treatment is no longer possible. AlzoSure® Predict, Diadem’s rapid, accurate and cost-effective blood-based prognostic test, will make it possible for the first time to identify patients early in the disease process, when effective interventions and better outcomes are far more feasible. It also could help make clinical trials of potential new therapies for AD more informative and efficient. The utility of the approach has been demonstrated in longitudinal clinical studies. Additional retrospective and prospective clinical trials are ongoing and planned to further validate clinical claims and support widespread adoption and use. Diadem’s founding lead investor is Milan-based Panakes Partners, a venture capital firm that finances promising high potential biomedical companies in Europe and Israel. Diadem is preparing for rapid commercialization of its initial Alzheimer’s prognostic via a global launch in collaboration with strategic partners. For more information, www.diademdx.com/.