Diadem has received the US Food and Drug Administration (FDA) Breakthrough Device Designation for the AlzoSure Predict blood test to predict the Alzheimer’s disease (AD).
According to the company, AlzoSure Predict is a blood-based biomarker prognostic assay intended for the early prediction of AD.
The test identifies the chances of Alzheimer’s disease progression in cognitive impairment patients, aged 50 years and above, up to six years prior to the onset of definitive symptoms.
Diadem CEO Paul Kinnon said: “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 US 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 regulatory application with the US FDA was based on positive data from a study of AlzoSure Predict in 482 cognitive impairment patients, aged 50 years or older.
The study showed that AlzoSure Predict is capable of identifying the likeliness of disease progression to full-fledged AD, up to six years prior to the symptomatic illness.
The second phase of this study, which includes biobank data on more than 1,000 additional patients from the US and Europe, is anticipated to be completed in the coming months.
Alzheimer’s disease is the most common form of dementia that accounts for 60-70% of cases, with no disease modifying treatments, and limited therapies to treat symptoms.
Diadem, a spin-off from the University of Brescia, Italy, is developing AlzoSure Predict as a simple, non-invasive plasma-based biomarker assay to predict the progression of AD.
The company’s leverages its patented antibody technology to target U-p53AZ, a conformational variant of the p53 protein, and its sequences.
