Diadem's AlzoSure Assay for Predicting Alzheimer's Designated a Breakthrough Device

Diadem’s AlzoSure Predict blood-based biomarker prognostic assay for the early prediction of Alzheimer's disease has received the FDA’s designation as a Breakthrough Device.

The assay is designed to identify with high accuracy whether people over age 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 assay features an antibody Diadem developed that is designed to bind to a variant of the p53 protein that has been implicated in the pathogenesis of Alzheimer’s disease in multiple studies. The application for breakthrough device status was supported by positive data from a 482-patient study.