—Further Analysis of Clinical Validation Data Shows Diadem’s AlzoSure® Predict Is Highly Concordant with Amyloid Brain Imaging—the Current Gold Standard for Diagnosing Alzheimer’s Disease—in All Individuals Tested—


—AlzoSure® Predict Identifies Individuals Who Will Progress to Alzheimer’s Disease Using Simple Blood Draw with High Accuracy Up to Six Years Before Diagnosis—

Milan, ITALY – October 6, 2021 Diadem srl, a company developing the first blood-based test for the early prediction of Alzheimer’s disease (AD), presented data showing that its AlzoSure® prognostic biomarker test is 84% concordant with amyloid brain imaging, the current gold standard for diagnosing AD. The new study results were presented at the 22nd International Conference on Alzheimer’s Drug Discovery. The Diadem assay uses a proprietary antibody to measure blood levels of a conformational variant of the p53 protein (U-p53AZ) that has been implicated in the pathogenesis of AD.

The presentation highlights clinical validation study data showing that a high concentration of U-p53AZ is already detectable at the preclinical stage, years in advance of symptom onset in study individuals who progress to AD. It discusses the multiple factors that impact U-p53AZ and make AlzoSure an effective integrative biomarker. These include the many downstream interactions of p53 with p-tau and 1-40/1-42 amyloid, as documented in over 400 papers that have investigated the scientific rationale for these biomarkers. The presentation included these new findings and recaps clinical validation study data showing that:

  • AlzoSure® Predict has an 84% concordance with amyloid brain imaging levels in all individuals tested (those individuals with uncertain status were counted as unconcordant)
  • AlzoSure® Predict is able to identify individuals in both the preclinical and early stages of the onset of Alzheimer’s with over 95% AUC (a measure of accuracy) up to six years in advance of diagnosis
  • AlzoSure® Predict clearly distinguishes between Alzheimer’s progressor and non-progressor individuals, and between those who have mild cognitive impairment (MCI) and those who have AD. In this study, amyloid brain imaging was not able to clearly discriminate between progressors and non-progressors or between individuals who are at preclinical stage or have MCI and those who have AD.

The data was presented on October 5, 2021, at the Alzheimer’s Drug Discovery Foundation’s 2021 International Conference on Alzheimer’s Drug Discovery by Simona Piccirella, PhD, Diadem’s Vice President of Product Development and Operations. Dr. Piccirella noted, “We have presented data from multiple studies showing that AlzoSure® Predict can accurately identify individuals at high risk of progressing to AD early in the disease process. This new data further confirms the accuracy of AlzoSure®, showing that it is highly concordant with amyloid brain imaging, the current gold standard for diagnosing AD. Unlike brain imaging, which is expensive and primarily available in specialized facilities, AlzoSure® Predict requires only a simple blood draw and analysis in a clinical laboratory, making it potentially widely accessible for screening and early diagnosis of AD.”

The presentation discussed selected results and new interpretations from the large retrospective longitudinal study of AlzoSure® Predict recently published by Diadem researchers as a Medrxiv preprint. It confirms that AlzoSure® Predict accurately identifies individuals with no or only minor cognitive impairments who will progress to fully symptomatic Alzheimer’s disease up to six years before dementia symptoms are evident, achieving AUC values of around 99% over the years of study follow-up. The data also confirmed the test’s capability to discriminate between patients at different stages of cognitive decline, from asymptomatic to mild impairment to full AD dementia. AlzoSure Predict® also demonstrated superior predictive performance to PET brain imaging measures of amyloid  load (P < 0.001), as well as AD-related genetic biomarkers. Separately, Diadem announced that it is presenting a scientific poster at the World Federation of Neurology’s XXV World Congress of Neurology, taking place October 3-7, 2021. The poster presentation, Prognosis of early onset of Alzheimer’s disease up to 6 years in advance by a conformational variant of p53 (U-p53AZ), includes key results from Diadem’s longitudinal Discovery cohort study of 225 individuals that provided an early confirmation of the prognostic value of AlzoSure® Predict for Alzheimer’s disease, as well as its utility in charting AD prognosis pathways.

Diadem is developing the AlzoSure® Predict assay as a simple, non-invasive plasma-based biomarker test to accurately predict the probability that a patient with asymptomatic mild cognitive impairment will progress to Alzheimer’s dementia. The company’s technology uses an analytical method that includes a proprietary antibody developed by Diadem designed to bind to the conformational variant U-p53AZ protein and its target sequences.

The company is conducting a follow-up study using additional longitudinal data from different cohorts and centers in Europe and the U.S. to validate these findings and compare and correlate the potential of U-p53AZ as a blood-based biomarker with traditionally studied markers of AD pathology. Results are expected in the coming months.

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-off 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 early clinical studies. Additional retrospective and prospective clinical trials are ongoing and planned to further validate clinical claims and support widespread adoption and use. Diadem’s founding lead investor is Milan-based Panakes Partners, a venture capital firm that finances promising high potential biomedical companies in Europe and Israel. Diadem is preparing for rapid commercialization of its initial Alzheimer’s prognostic via a global launch in collaboration with strategic partners. For more information, visit www.diademdx.com/.