Diadem srl, a company developing the first blood-based test for the early prediction of Alzheimer's disease (AD)

Milan,Italy - May 13, 2021

Diadem srl, a company developing the first blood-based test for the early prediction of Alzheimer's disease (AD), today announced new data showing that its AlzoSure® prognostic biomarker test can accurately predict progression to Alzheimer's disease six to seven years before symptoms appear. The new study results are being presented today at the 2021 Alzheimer's Association International Conference® (AAIC) Satellite Symposium. Results of the study are available as a preprint1 and are also being submitted for publication in a peer-reviewed journal.

The Diadem assay uses a proprietary antibody 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 predictive biomarker to identify individuals likely to progress to AD up to six years before symptoms appear.

The new study is based on health data collected from 224 participants in the Australian Imaging, Biomarkers, and Lifestyle Flagship Study of Aging (AIBL). The well-characterized cohort includes extensive longitudinal patient data and plasma samples. The prognostic performance of Diadem's biomarker test in predicting progression to Alzheimer's dementia was high, with "area under the curve" values (a measure of the accuracy of a quantitative diagnostic test) above 0.90 for both preclinical pre-symptomatic patients and for prodromal stage patients beginning to manifest early dementia symptoms.

The study results indicated promising positive and negative predictive values of about 90% when predicting the progression to AD dementia more than 6 years prior to symptom onset. Additionally, the prognostic performance of the Diadem biomarker test was superior to covariate measures including age, gender, and APOE-related genetic susceptibility, either alone or in combination with amyloid status. The Diadem biomarker test also achieved high diagnostic performance in the ability to differentiate cognitively normal individuals from patients with AD dementia.

The data are being presented today at the AAIC Satellite Symposium by Simona Piccirella, PhD, Diadem's Vice President of Product Development and Operations. Dr. Piccirella noted, "Our ability to accurately identify individuals at high risk of progressing to AD early in the disease process, when effective disease-modifying interventions are still feasible, is a game-changer. Our simple, affordable and accessible blood-based technology will enable individuals to be widely screened in primary care settings, setting the stage for achieving tangible progress against this devastating disease that could benefit millions of people worldwide."

Diadem is developing the AlzoSure assay as a simple, non-invasive plasma-based biomarker test to accurately predict the probability that a patient with asymptomatic mild cognitive impairment (MCI) will progress to Alzheimer's dementia. The company's patented technology uses an analytical method that includes a proprietary antibody designed to bind to the conformational variant U-p53AZ protein and target sequences developed by Diadem. Diadem is currently conducting further validation studies in about 1000 subjects, with additional results expected this year. The company plans to initiate a global launch in collaboration with strategic partners within the next 12 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 dollars 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 diagnostic and prognostic methods.

1. Piccirella, S.; Uberti, D.; Xiong, C.; Fowler, C.; Doecke, J.; Fagan, A.; Frisoni, G.; Kinnon, P. Performance of a Non-Invasive Blood Test for a Conformational Variant of p53 to Predict Alzheimer's Disease Within 6 Years of Clinical Diagnosis. Preprints 2021, 2021050267 (doi: 10.20944/preprints202105.0267.v1)

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, cost effective and predictive 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 to further validate clinical claims and support widespread adoption and use are underway or planned. 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/.