FDA Grants Breakthrough Device Designation to Diadem’s AlzoSure® Predict
Prognostic Blood Test for the Early Prediction of Alzheimer’s Disease
—First Prognostic Blood Test that Can Predict Likely Progression to Alzheimer’s Disease Up to Six Years in Advance—
—Clinical Studies Show AlzoSure® Predict Can Identify with High Accuracy Whether Individuals with Early Cognitive Impairment Will or Will Not Progress to Alzheimer’s Disease—
The FDA Breakthrough Designation is granted to novel medical devices that have the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions. The Breakthrough Device designation allows companies to benefit from additional FDA input as they work to validate the safety and efficacy of their devices during development and during the regulatory submission process, with expedited review once the company files for marketing approval.
Diadem’s application was supported by positive data from a 482-patient longitudinal study showing that AlzoSure® Predict 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 the U.S. and Europe, is due for completion in the coming months.
“Obtaining this FDA Breakthrough Device designation reinforces our view that AlzoSure® Predict is a potential game changer for the early identification and management of Alzheimer’s disease, which afflicts millions of patients and their families worldwide,” said Paul Kinnon, CEO of Diadem. “We see the Breakthrough Device designation as an important step in supporting the future commercialization of AlzoSure® Predict in the U.S and globally, and we look forward to working closely with the FDA to complete our clinical studies and expedite the regulatory review process.”
Diadem is developing the AlzoSure® Predict assay as a simple, 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 and 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.
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/.