The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Diadem’s AlzoSure Predict, a blood-based biomarker prognostic assay designed to identify early signs of Alzheimer’s disease and determine the potential rate of progression in patients up to six years before definitive symptoms are expressed. Alzheimer’s disease (AD), the most common form of dementia, involves a lengthy, often inconclusive, and invasive diagnosis as cognitive functions, behavioral and social skills decline with age. AlzoSure Predict is being developed as a non-invasive plasma-based biomarker that uses a proprietary antibody to bind to U-p53AZ, a conformational variant of the p-53 protein, that has been associated with the pathogenesis of AD. Currently, there is no cure for AD and a diagnosis can be confirmed through a number of tests including: physical examination, complete blood count (CBC), MRI, CT scan, and neurological examination. Diadem is an Italian-based biotech company that focusses on developing treatments to predict, monitor, and diagnose Alzheimer’s disease.
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