DIADEM PRESENTS NEW DATA AT AAIC® SYMPOSIUM SHOWING ITS BLOOD-BASED BIOMARKER TEST ACCURATELY PREDICTS PROGRESSION TO ALZHEIMER’S DISEASE 7 YEARS BEFORE SYMPTOMS OCCUR

—Analysis of 224 Longitudinal Patient Samples Confirms Diadem’s Prognostic Biomarker Can Predict Progression to AD Early in the Disease Process with >90% Accuracy—

—Study Results Also Available in Newly-Released Preprint—

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.