Diadem SpA announced publication of the results of a clinical validation study of its AlzoSure Predict prognostic blood test for Alzheimer’s disease (AD). The article, A Conformational Variant of p53 (U-p53AZ) as Blood-Based Biomarker for the Prediction of the Onset of Symptomatic Alzheimer’s Disease, appears in the online edition of the Journal of Prevention of Alzheimer’ Disease. The authors conclude that AlzoSure® Predict accurately identifies whether or not individuals with no or only minor cognitive impairments will progress to Alzheimer’s disease up to six years before they are diagnosed using conventional criteria.
AlzoSure Predict precisely measures the presence in patient plasma of an unfolded conformational variant of the p53 protein (U-p53AZ), which multiple studies have shown to be associated with AD. The retrospective longitudinal prognostic study evaluated plasma samples from 482 individuals aged 60 or older participating in the Australian Imaging, Biomarkers and Lifestyle (AIBL) cohort over the course of six years. Diagnostic classifications were independently validated using well-established neuropsychological-based criteria and measurements of amyloid load determined via amyloid β-positron emission tomography (Aβ-PET) imaging and supporting clinical information were included when possible.
The diagnostic and prognostic performance of AlzoSure Predict was assessed in both time-independent and time-dependent (36, 72 and 90 months following initial sampling) analyses. The prognostic performance of Aβ-PET and analyses with several different risk factors (gender, Aβ-PET and APOE ε4 allele status) were also assessed.
Study results confirm that the levels of U-p53AZ in patient samples measured by AlzoSure Predict were a major independent predictor of the onset of Alzheimer’s disease. AlzoSure Predict successfully differentiated individuals with and without Alzheimer’s disease and it accurately determined the risk of progressing to a confirmed AD diagnosis over time, identifying those people who would progress to future symptomatic AD up to six years before diagnosis using standard criteria. AlzoSure Predict achieved area under the curve (AUC) >98%, significantly higher than the AUC’s achieved using the “gold standard” of Aβ-PET imaging (between 84% and 93%, with P= <0.0001 and <0.001, respectively).