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January 2022

FDA Grants Breakthrough Device Designation to Diadem’s AlzoSure® Predict Prognostic Blood Test for the Early Prediction of Alzheimer’s Disease 

Diadem U.S. Inc. - a subsidiary of Diadem Srl, based at OpenZone campus -  a company developing the first blood-based test for the early prediction of Alzheimer’s disease (AD), announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for AlzoSure® Predict, Diadem’s blood-based biomarker prognostic assay designed to 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 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.
 
Paul Kinnon
CEO at Diadem

 

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. 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.

 

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