‘Breakthrough Device’ designation from FDA granted to Alzheimer’s prognostic test ‘AlzoSure’

A novel blood-based biomarker prognostic testing for Alzheimer’s disease was recently given a “Breakthrough Device” designation by the FDA. AlzoSure Predict, by Diadem U.S., is 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.

Diadem is a diagnostic company that seeks to carry out specific research and development on early peripheral markers of Alzheimer’s disease into technology. Its primary product, AlzoSure Predict,  is a blood-based test targeting a specific conformation of p53 protein. This biomarker, known to be associated with several patients’ inflammatory conditions, has shown to be highly specific for Alzheimer’s disease onset, providing a signal also in the pre-symptomatic population. 

Alzheimer’s disease is ranked as the third leading cause of death for the elderly in the United States, just behind heart disease and cancer. Alzheimer’s is the most common cause of dementia among older adults, which is the loss of cognitive functioning and behavioral abilities to such an extent that it interferes with a person’s daily life and activities.

As Alzheimer’s disease worsens, people experience greater memory loss and other cognitive difficulties. Problems in the mild stages can include wandering and getting lost, repeating questions, and personality and behavior changes. People are often diagnosed in the stage of mild cognitive impairment. If Diadem’s AlzoSure Predict is successful, however, patients could know much sooner if Alzheimer’s is on the horizon.

“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,” says Paul Kinnon, CEO of Diadem, in a press release. “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’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 Alzheimer’s 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 Alzheimer’s. 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.

The FDA Breakthrough Device 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 designation allows companies to benefit from additional FDA input as they work to validate the safety and efficacy of their devices during development and the regulatory submission process. Upon submission, the designation allows for an expedited review once the company files for marketing approval.

Article by Rhonda Errabelli

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Steve Fink

Steve Fink is the Editor-in-Chief of BrainTomorrow.com, GutNews.com and StudyFinds.com. He is formerly the Vice President of News Engagement for CBS Television Stations’ websites, and spent 20 years with CBS.

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