Diadem Presents Data at 2023 AAIC® Showing Its AlzoSure® Blood Test Can Identify Patients at High Risk of Significant Cognitive Decline Due to Alzheimer's Disease

—Data from 479-Patient Study Confirms Strong Prognostic Utility of AlzoSure^® Predict for Identifying Whether or Not Individuals Will Experience a Significant Cognitive Decline due to Alzheimer's Disease (AD) Within a 2-Year or 6-Year Timeframe—

—Ability to Identify "Rapid Progressors" Who Will Develop AD Within 2 Years Is Especially Valuable Now that Treatments for Early AD are Available—AlzoSure^® Predict Can Facilitate Access to Effective Treatment for At-Risk Patients and Help Accelerate New Drug Research— 

—Diadem Anticipates AlzoSure^® Predict Will Be Commercially Available in the U.S. in the Next 12 Months—

MILAN and AMSTERDAM, July 19, 2023 /PRNewswire/ -- Diadem SpA, a company developing the first blood-based test for the early prediction of clinical progression to Alzheimer's disease (AD), today announced that study data being presented at the Alzheimer's Association International Conference^® 2023 (AAIC^®) further strengthens the evidence supporting the prognostic value of Diadem's AlzoSure^® Predict blood-based biomarker test, which can accurately identify whether or not individuals over the age of 50 will experience a significant cognitive decline due to AD years before the full onset of symptoms. The study data are included in a scientific poster¹ that is being presented today at AAIC^® 2023.

The Diadem AAIC^® 2023 analysis confirms the strong prognostic performance of AlzoSure^® Predict in AD based on longitudinal data from 479 individuals aged 60-85 who participated in the Australian Imaging, Biomarkers and Lifestyle (AIBL) study. It is comprised of individuals who are cognitively normal or who have minimal cognitive impairment, as well as those with dementia due to Alzheimer's disease or a non-AD source. This dataset includes comprehensive medical data on the participants, including blood samples collected over time. It allowed researchers to evaluate the performance of AlzoSure^® Predict in assessing the risk that study participants would experience a significant cognitive decline to AD over time, and in identifying the time frame during which this decline would occur (2 years for "rapid progressors" and 6 years for "slow progressors.")

The performance of AlzoSure^® Predict in this study was high. For prediction of deterioration to AD within 2 years, the area under the curve (AUC) is 99.8%, and for decline to AD within 6 years, the AUC is 98.4%. AUC is a measure of the accuracy of a quantitative diagnostic test. A test with accuracy that is no better than chance has an AUC of 0.5, or 50%,  and a test with perfect accuracy has an AUC of 1, or 100%.

The cut-off values of AlzoSure^® Predict are defined to stratify individuals, at the time of testing, according to the time frame during which they may experience a significant cognitive decline. AlzoSure^® Predict showed high performance in identifying whether or not an individual was a rapid progressor who would cognitively decline to AD within 2 years, with a positive predictive value/negative predictive value (PPV/NPV) of greater than 90% and specificity of greater than 95%.

Diadem CEO Paul Kinnon noted, "These data further confirm AlzoSure^® Predict's utility as a tool for managing AD, enabling personalized clinical decision-making with improved precision that can be used by healthcare providers to identify whether or not a patient is at high risk of suffering cognitive decline to Alzheimer's dementia in the coming 2 years or the coming 6 years. The opportunity to present clinical validation data for AlzoSure^® Predict at AAIC 2023 could not be more timely, as the recent FDA approval of lecanemab highlights the need for accurate and accessible screening tools to help providers and patients make informed treatment-related decisions. As an example, a physician will be better able to help patients and their families assess the trade-offs in choosing whether or not to take new disease-modifying drugs with potential side effects and substantial costs, with the knowledge of when a clinical deterioration to AD dementia is expected."

Mr. Kinnon continued, "AlzoSure^® Predict also allows drug developers to screen, enrich and stratify patient populations to enhance clinical trials for new AD drugs. In particular, the ability to identify, in advance, the expected time-frame for cognitive decline will enable pre-hoc identification of sub-populations of interest and allow clinical researchers to enrich the study with patients with the desired rate of progression to AD."

Mr. Kinnon concluded, "We expect to launch AlzoSure^® Predict in the U.S. within the next 12 months in partnership with a major diagnostics firm and look forward to working with healthcare decision-makers to ensure it is widely accessible to patients and their families."

AlzoSure^® Predict is a non-invasive biomarker blood test that 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. The utility of AlzoSure^® Predict is supported by clinical data from a large longitudinal study that was the basis for AlzoSure^® Predict's Breakthrough Device designation from the U.S. Food & Drug Administration and its CE-IVD marking in the E.U. AlzoSure^® Predict requires only 1mL of blood and 4 to 5 days for analysis to detect AD at the asymptomatic and early symptomatic stage. Previous research also demonstrated that AlzoSure^® Predict can discriminate between the different kinds of dementia with high accuracy.

1--The performance of AlzoSure^® Predict in stratifying the risk to experience a significant cognitive deterioration due to Alzheimer's Disease, Sam Agus, Simona Piccirella, Leander Van Neste, Christopher Fowler, Colin L Masters, Jurgen Fripp, James D. Doecke, Daniela Uberti, Paul Kinnon, Alzheimer's Association International Conference^® 2023, Poster #76902, July 19, 2023, 8:45am-4:15pm CEST.

About Diadem
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 has contributed to the lack of effective treatments for this devastating condition. As a result, patients have not been diagnosed until late in the illness, when effective treatment is less feasible. Diadem's rapid, accurate and cost-effective blood-based prognostic test makes it possible to identify patients early in the disease process, when effective interventions and better outcomes are now potentially achievable. 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 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/.

SOURCE Diadem SpA