Diadem Unveils AlzoSure® Blood Test at 2023 AAIC®, Offering Hope to Spot Alzheimer’s High-Risk Patients Before Significant Cognitive Decline

At the Alzheimer’s Association International Conference® 2023 (AAIC®), Diadem SpA presented a study that further highlighted the potential value of its AlzoSure® Predict blood-based biomarker test.

These data showed that the test could accurately detect whether individuals over the age of 50 would experience a distinct cognitive decline due to Alzheimer’s disease up to years before its full onset. The highly anticipated results of this groundbreaking test which could revolutionize the prevention and treatment of Alzheimer’s, was presented through a scientific poster at the conference.

The Diadem AAIC® 2023 analysis has explored the validity of AlzoSure® Predict in accurately predicting the risk of developing Alzheimer’s disease (AD). Data from 479 senior participants enrolled in the Australian Imaging, Biomarkers and Lifestyle (AIBL) study provided valuable insight into the performance of AlzoSure® Predict.

Blood samples were taken over time, measuring both individuals who had minimal cognitive impairment as well as those with dementia due to AD or non-AD causes. This data was used to calculate the likelihood of a participant’s cognitive decline to AD within a two-year timeframe (for rapid progressors) or six-year timeframe (for slow progressors). The results of this analysis demonstrate the reliability and accuracy of AlzoSure® Predict in anticipating AD and its progression.

AlzoSure® Predict demonstrated a remarkably superior performance in this study, with an area under the curve (AUC) of 99.8% for prediction of deterioration to AD within 2 years, and an AUC of 98.4% for decline to AD within 6 years. To put it into context, a test with no better than chance accuracy has an AUC of 0.5, or 50%, whereas one with perfect accuracy yields an AUC of 1, or 100%.

AlzoSure® Predict is a powerful tool designed to help identify if an individual is at risk of experiencing a significant cognitive decline within two years. It has been proven to successfully predict rapid progressors, with an impressive PPV/NPV of greater than 90% and specificity of greater than 95%. With its accurate cut-off values, AlzoSure® Predict can give peace of mind regarding cognitive decline risk and help guide clinicians and individuals in making informed decisions.

At the upcoming Alzheimer’s Association International Conference (AAIC) in 2023, Diadem CEO Paul Kinnon is pleased to have the opportunity to present clinical validation data for AlzoSure® Predict, Diadem’s breakthrough tool for accurately predicting whether or not a patient is likely to experience cognitive decline to Alzheimer’s dementia in the coming 2 to 6 years.

Having been recently FDA approved, the continued development of such screening tools are essential in helping providers and patients make informed treatment-related decisions, such as weighing the possible side effects and costs of taking new disease-modifying drugs. AlzoSure® Predict may therefore provide an invaluable resource for understanding when a clinical deterioration to AD dementia is likely to occur.

AlzoSure® Predict provides a revolutionary new tool for drug developers to streamline clinical trials for new AD drugs. With its unique ability to identify and stratify patient populations in advance, researchers can gain valuable insights into the expected time-frame for cognitive decline.

This allows them to pre-select the patient sub-populations of relevance to the study and enrich the trial with people exhibiting the desired rate of progression to AD. Utilizing AlzoSure® Predict’s cutting-edge technology, drug developers can now more effectively and efficiently move towards the development of life-changing treatments.

Mr. Kinnon is thrilled to announce that AlzoSure® Predict will be available in the United States within the next year, thanks to a partnership with a leading diagnostics firm. This revolutionary product will make it easier than ever for healthcare decision-makers to provide patients and their families with fast and accurate medical testing. We look forward to transforming the field of medical diagnostics and providing access to the latest technology to all individuals in need.

AlzoSure® Predict is an innovative, non-invasive biomarker test that uses a special antibody (U-p53AZ) to detect the presence of a form of p53 protein linked to Alzheimer’s Disease (AD) at the asymptomatic and early symptomatic stages. It has been scientifically proven to differentiate between different kinds of dementia with an incredibly high accuracy rate.

What’s more, with only 1mL of blood and a 4-5 day procedure window required, AlzoSure® Predict is a groundbreaking Breakthrough Device designated by the U.S. Food and Drug Administration and also has the CE-IVD marking in the E.U. – truly a revolutionary advancement in the fight against dementia.

About Diadem

Diadem is revolutionizing the fight against Alzheimer’s disease and dementia with its groundbreaking blood-based prognostic test, AlzoSure® Predict. Utilizing a quick, accurate and cost-effective approach, AlzoSure® Predict is able to identify patients in the early stages of the disease, when interventions and better outcomes are still feasible.

It has received both CE-IVD marking in the European Union and Breakthrough Device designation in the United States. To further validate its clinical claims and support adoption and use, Diadem is conducting several retrospective and prospective clinical trials.

Diadem is also developing AlzoSure® Confirm, a second blood-based diagnostic test that has already yielded promising results. Diadem is making strong progress towards commercialization of AlzoSure® Predict in partnership with global strategic partners.

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