Diadem Announces Publication of Clinical Study Confirming Its AlzoSure® Predict Blood Test Can Accurately Predict Progression to Alzheimer's Disease Six Years Before Diagnosis

—AlzoSure® Predict Uses a Simple Blood Draw to Identify with High Accuracy Whether or Not Individuals Will Progress to Alzheimer's Disease Up to Six Years Before Diagnosis—

—Prognostic Performance for Progression to Alzheimer's Significantly Better than PET Amyloid Imaging—

—AlzoSure Predict Is an FDA-Designated Breakthrough Device and CE-IVD Marked in the E.U.—

MILAN, May 16, 2022 /PRNewswire/ -- Diadem SpA today 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=

The study authors conclude that these findings support the use of AlzoSure Predict as a blood-based biomarker test to predict whether or not individuals will progress to neuropsychologically-defined Alzheimer's disease up to six years prior to the AD diagnosis. They note that the assay could be useful in enabling participant stratification for interventional studies assessing new AD therapies, while also calling for additional studies to confirm and extend these results.

Study author Colin L Masters MD, professor of dementia research at the University of Melbourne and Head of the Neuropathology and Neurodegeneration Laboratory at Australia's Florey Institute of Neuroscience, commented, "There is growing interest among physicians and the public for access to tools enabling early identification of individuals likely to develop Alzheimer's disease, both to enable those at-risk to seek early interventions, as well as to facilitate the development of effective disease modifying therapies. These encouraging data suggest that AlzoSure Predict has the potential to play a valuable role in identifying patients who will progress to Alzheimer's disease years before they develop full-blown clinical dementia. The fact that it is a simple, potentially cost-effective, and accurate blood test suggests that AlzoSure Predict could play an important role, along with other innovations in AD diagnosis and treatment, in enabling more effective management of this devastating disease."

Paul Kinnon, Chief Executive Officer of Diadem, stated, "There is growing recognition that biomarker tests can play a critically important role in improving the management of Alzheimer's disease. This new peer-reviewed publication confirms that AlzoSure Predict uniquely has the ability to accurately identify individuals with no symptoms or only mild cognitive symptoms who will progress to full-blown AD up to six years prior to diagnosis. Importantly, the test requires only a simple blood draw and widely available laboratory instruments, making it suitable for broad-based public health screening applications. The potential of AlzoSure Predict was recently recognized by an FDA Breakthrough Device designation and granting of CE-IVD marking, allowing us to begin marketing the test in the E.U. We aim to complete additional validation studies in the coming months and are targeting launches in collaboration with strategic partners beginning later this year."

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 recent CE-IVD marking, which allows the test to be marketed in the E.U., 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-p53AZ and its target sequences. U-p53AZ is a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD in multiple studies.

About Alzheimer's Disease There are about 50 million people suffering from dementia worldwide. Alzheimer's disease is the most common form and accounts for 60-70% of cases. At present there are no disease modifying treatments for Alzheimer's, and therapies to treat symptoms are limited. There are about 10 million new cases per year, and the incidence is rising rapidly as the population ages. The current total cost of care is enormous--estimated at $1 trillion in the U.S. annually and expected to double by 2030. Currently, diagnosis of Alzheimer's disease is slow, inconclusive, invasive and expensive. Development of effective therapies for Alzheimer's has been hindered by the lack of accurate and cost-effective prognostic and diagnostic methods.

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 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