Diadem Presents Data at 2022 Alzheimer's Association International Conference® Showing Its Blood-Based Biomarker Test Can Both Diagnose and Predict Alzheimer's Disease

—Data from 479 Patient Study Confirms Strong Diagnostic Value of Diadem's AlzoSure^® Predict and Its   High Prognostic Accuracy for Predicting Who Will Progress to Alzheimer's Disease (AD)—

—Demonstrated >95% Sensitivity in Diagnosing AD and Superiority to Amyloid PET Imaging in Predicting Whether Individuals Who Have Not Yet Manifested Clinical Symptoms Will Progress to AD—

—To Learn More About AlzoSure^® Predict, Visit Diadem Booth 1010 at AAIC^® 2022—

SAN DIEGO and MILAN, Aug. 2, 2022 /PRNewswire/ -- Diadem srl, a company developing the first blood-based test for the early prediction of Alzheimer's disease (AD), today reported that study data presented at the Alzheimer's Association International Conference^® 2022 (AAIC^®) in San Diego, USA confirms the strong diagnostic value of Diadem's AlzoSure^® Predict blood based biomarker test, as well as its excellent performance in identifying whether or not individuals will progress to AD years before the manifestation of clinical symptoms. The study data are included in a poster presentation¹ that is being presented at AAIC^® 2022 on August 3, 2022.

AlzoSure^® Predict uses a proprietary antibody (U-p53^AZ) to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD. Previous studies suggest that this p53 variant has utility as a diagnostic and as a predictive biomarker to identify individuals likely to progress to AD up to six years before symptoms appear.

The data Diadem is presenting at AAIC^® 2022 confirms the diagnostic performance of AlzoSure^® Predict for Alzheimer's disease and highlights its potential as a prognostic test. They are based on a longitudinal cohort of 479 individuals aged 60-85 years old in the Australian Imaging, Biomarkers, and Lifestyle (AIBL) study. In the present study, the assay achieved a sensitivity of 95% for AD, discriminating patients with AD from subjects with no memory complaints, with an AUC of 99.8% and a specificity of 99.6%, and from patients at the early symptomatic stage of AD with an AUC of 95.7% and a specificity of 91.8%.

In the prognostic setting, AlzoSure^® Predict showed a significantly better performance (P<0.0001) in distinguishing whether or not subjects would progress to AD compared to amyloid beta PET imaging, with an AUC of 99.0% achieved by AlzoSure^® Predict compared to an AUC of 83.5% reported for amyloid PET imaging (this analysis included the 422 cohort members with amyloid PET imaging data.)

Diadem CEO Paul Kinnon commented, "We welcome the opportunity to present these study data at this important global meeting highlighting the performance of AlzoSure^® Predict as both a diagnostic and prognostic test for Alzheimer's disease. Based on these data and other studies, we are confident that AlzoSure^® Predict has the potential to contribute to significant advances in the management of this devastating disease. We also are in the process of conducting additional studies to further confirm the prognostic power and utility of AlzoSure^® Predict."

AlzoSure^® Predict is a non-invasive biomarker blood test that can identify with high accuracy whether individuals over the age of 50 with signs of cognitive impairment will or will not progress to Alzheimer's disease up to six years before diagnosis. Its utility is supported by clinical data from a large longitudinal study that was the basis for AlzoSure^® Predict's CE-IVD marking, as well as for a Breakthrough Device designation from the U.S. Food & Drug Administration. The company's technology uses an analytical method that includes a patented antibody developed by Diadem and designed to bind to U-p53^AZ and its target sequences. U-p53^AZ is a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD in multiple studies.

Diadem representatives are available to discuss AlzoSure^® Predict at Booth 1010 at the AAIC^® 2022 meeting.

1. AlzoSure^® Predict, a simple, minimally-invasive blood test to predict the early onset of Alzheimer's disease before the manifestation of clinical symptoms, Simona Piccirella, Leander Van Neste, Christopher Fowler, Colin Masters, Jurgen Fripp, James D. Doecke, Chengjie Xiong, Daniela Uberti, Paul Kinnon

Diadem was founded as a spin-out of the University of Brescia (Italy). The company is developing the first blood-based prognostic test for the early detection of dementia, with a focus on Alzheimer's disease. The lack of accurate, accessible and affordable diagnostic tools is a major contributor to the absence of effective treatments for this devastating condition. As a result, patients are not diagnosed until late in the illness, when effective treatment is no longer possible. Diadem's rapid, accurate and cost-effective blood-based prognostic test makes it possible for the first time to identify patients early in the disease process, when effective interventions and better outcomes are far more feasible. The utility of the approach has been demonstrated in longitudinal clinical studies that were the basis for awarding CE-IVD marking in the E.U. and a Breakthrough Device designation in the U.S. Additional retrospective and prospective clinical trials are ongoing to further validate clinical claims and support widespread adoption and use. Diadem is preparing for commercialisation of AlzoSure^® Predict in collaboration with global strategic partners. The company is also developing AlzoSure^® Confirm, a blood-based diagnostic test for AD that has shown promising results in early studies. For more information, visit diademdx.com/.

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SOURCE Diadem SpA