Diadem

Diadem, founded in 2012 as a spin-out from the University of Brescia in Italy, is a biotechnology firm focused on developing a prognostic blood test for the early detection of Alzheimer's disease. The company's headquarters are in Milan, Italy, with a U.S. subsidiary in Palo Alto, California. The company's scientific foundation is credited to Professor Daniela Uberti, a leader in researching the role of a specific p53 protein variant in the development of Alzheimer's. Paul Kinnon, a veteran with over 30 years in the clinical diagnostics and life sciences industries, was appointed CEO in October 2020 to steer the company through its commercial growth phase. His extensive experience includes leadership roles at companies like PredictImmune, Transgenomic, and Life Technologies (now ThermoFisher).

Diadem is addressing a critical unmet need in the healthcare market for an accurate, non-invasive, and cost-effective method for early Alzheimer's diagnosis. The company's flagship product is AlzoSure® Predict, a blood test designed to determine the likelihood of an individual progressing to Alzheimer's disease up to six years before clinical symptoms become apparent. This test requires just 1mL of blood and targets a conformational variant of the p53 protein (U-p53AZ), a biomarker implicated in the pathogenesis of the disease. AlzoSure® Predict has demonstrated high accuracy, with studies showing it can predict cognitive decline with an AUC (Area Under the Curve) greater than 90%. This predictive capability is valuable for both patients, who can seek earlier interventions, and for pharmaceutical companies, as it helps in the screening and stratification of patient populations for clinical trials.

The company's business model revolves around the commercialization of its diagnostic tests through strategic partnerships and licensing agreements. A significant milestone was achieved in October 2023 when Diadem entered into an exclusive U.S. licensing agreement with Quest Diagnostics. Under this agreement, Quest will develop, validate, and market a laboratory-developed test service based on the AlzoSure® Predict technology. Diadem has received substantial financial backing from various sources, including venture capital firms like Panakès Partners and CDP Venture Capital, as well as grants from the European Investment Bank and the U.S. National Institute on Aging (NIA). The test has earned a Breakthrough Device designation from the U.S. FDA and is CE-IVD marked in the European Union, permitting its marketing in the EU and the UK. Diadem is also developing a follow-up diagnostic test, AlzoSure® Confirm.

Keywords: Alzheimer's diagnosis, blood test, prognostic, p53 protein, neurodegenerative disease, biotechnology, medical diagnostics, early detection, AlzoSure Predict, CE-IVD mark, FDA Breakthrough Device, University of Brescia spin-out, Quest Diagnostics partnership, clinical trials, biomarker, cognitive impairment, dementia, U-p53AZ, Paul Kinnon, Daniela Uberti, non-invasive diagnostic, patient stratification, prognostic assay, molecular medicine, laboratory-developed test