Diadem

About

Diadem is a Milan-based spin-out developing AlzoSure® Predict, a non-invasive plasma biomarker blood test using a patented antibody to detect U-p53AZ and predict Alzheimer’s progression years ahead.

Mission

Diadem is a Milan, Italy–based spin-out of the University of Brescia developing AlzoSure® Predict, a non-invasive plasma biomarker blood test to predict progression to Alzheimer’s disease. The assay can identify with high accuracy whether individuals over age 50 with signs of cognitive impairment will or will not progress to Alzheimer’s dementia up to six years before definitive symptoms. Diadem’s technology uses an analytical method that includes a patented antibody designed to bind to U-p53AZ, a conformational variant of p53 implicated in AD pathogenesis. Clinical utility is supported by data from a large longitudinal study, and AlzoSure® Predict has gained a CE‑IVD mark and an FDA Breakthrough Device designation. The company is led by Dr. Gerald Möller (Chairman of the Board) and plans to continue global commercialization and further clinical validation of the test. Its current financing activity includes an equity tranche closing and a separate venture loan commitment from the EIB. Diadem develops a blood-based diagnostic kit intended to detect Alzheimer’s at asymptomatic and very early stages, claiming >95% AUC accuracy in clinical validation on AIBL longitudinal biobank samples. The company positions its test as non-invasive, inexpensive and more accurate than current early-detection tools, aiming to address a major bottleneck for effective therapeutic trials. Diadem plans to progress the test through clinical trials and seek regulatory approval in the EU and US, targeting CE marking in Europe by the end of 2019. The financing announced is intended to validate and launch the diagnostic kit and support final validation for regulatory approval. The company has used the investment to recruit experienced industry and clinical advisors and board members, including Francesco Granata, Antonio Boniolo, Antonella Fassio, Jeff Cummings and Robert Dean. Diadem is an academic spin-off operating from Milan and London.

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