NEW YORK — Diadem US, the Palo, Alto, California-based subsidiary of Italian firm Diadem, said on Wednesday that it has received a $2.5 million National Institutes of Health grant to continue validation of its blood-based test for predicting progression to Alzheimer's disease.
The test, called AlzoSure Predict, uses a proprietary antibody to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of Alzheimer's disease, according to Diadem. In January, the assay received breakthrough device designation from the US Food and Drug Administration.
With the two-year grant from the NIH, Diadem said it will screen data from the Alzheimer's Disease Neuroimaging Initiative (ADNI) to identify participants who were early progressors to the disease to help validate AlzoSure Predict's ability to identify such patients years before diagnosis.
Specific aims of the NIH-funded effort include validating the test's ability to discriminate the different stages of cognitive decline; establishing its specificity for AD compared to other dementias; confirming its prognostic clinical utility by categorizing patients into disease classes and stages; and comparing its performance against current diagnostic and prognostic methods for Alzheimer's disease.
"We have previously published compelling data documenting the accuracy and utility of AlzoSure Predict using the highly regarded [Australian Imaging, Biomarker, and Lifestyle Flagship Study of Aging] longitudinal patient cohorts from Australia," Diadem US CEO Paul Kinnon said in a statement. "We look forward to working with the distinguished group of [Alzheimer's disease] consultants we have assembled to replicate and potentially extend our clinical analyses using the comprehensive and well-characterized patient information available through ADNI."