European Investment Bank to Provide a €7.5 Million Loan to Support Further Research
and Development of Diadem’s AlzoSure® Predict Blood Test for Alzheimer’s Disease
• First CE-IVD-marked blood test that predicts likely progression to Alzheimer’s disease up to six years in advance of definitive symptoms
• Received Breakthrough Device designation from U.S. FDA
• Investment supported by European Guarantee Fund’s Venture Debt Loan Programme
Headquartered near Milan, Italy, Diadem was founded in 2012 as a spin-out of the University of Brescia (Italy), with the support of the Italian Ministry of Education, Universities and Research. It is considered to be one of the most promising Italian biotech SMEs (small and mid-size enterprises).
AlzoSure® Predict is a non-invasive biomarker blood test that can identify with high accuracy whether individuals over the age of 50 with signs of cognitive impairment will or will not progress to Alzheimer’s disease up to six years before definitive symptoms are apparent. Its utility is supported by clinical data from a large longitudinal study that was the basis for AlzoSure® Predict’s recent CE-IVD marking, which allows the test to be marketed in the EU, as well as for a Breakthrough Device designation from the U.S. Food & Drug Administration.
The excellent accuracy of AlzoSure® Predict and its ability to identify individuals at risk of progressing to AD early in the disease process are expected to contribute to one of the priorities of the World Health Organization (WHO), which estimates over 10 million new cases of Alzheimer’s dementia are diagnosed each year. Among other actions, WHO highlights the need for earlier diagnosis to improve the treatment options for people with Alzheimer’s disease.
EIB Vice-President Gelsomina Vigliotti said: “Diagnostics for neurodegenerative conditions such as Alzheimer’s disease have not been able to identify patients early enough in the disease process to allow interventions to slow or stop disease progression. With this investment, the EIB is confirming its commitment to research and to companies such as Diadem that are at the forefront of biotechnology innovation. We expect this EIB funding will help contribute to a revolution in Alzheimer's disease diagnostics, through the ability of AlzoSure® Predict to enable precise and early prediction of which individuals will progress to Alzheimer’s disease.”
Paul Kinnon, CEO of Diadem, noted, “As a company whose innovative technology was discovered and developed in Italy, we are proud to receive this vote of confidence and financial support from EIB. We believe AlzoSure® Predict represents a significant advance for the millions of patients in Europe at risk from Alzheimer’s disease. Earlier knowledge will benefit those individuals found to be at risk, who can now take steps to slow the progression of the disease, as well as those who are found to be at low risk of advancing to AD. We also expect that the availability of AlzoSure® Predict will facilitate the development of promising new therapies. Diadem intends to partner with health providers to ensure wide access to AlzoSure® Predict and we expect the test to be available in the EU later this year.”
About the European Investment Bank
The European Investment Bank (EIB) is the long-term lending institution of the European Union owned by the Member States. It provides long-term funding for sound investments to contribute to the EU's strategic objectives. The Bank finances projects in four priority areas: infrastructure, innovation, climate and environment, and small and medium-sized enterprises (SMEs). Between 2019 and 2021, the EIB Group provided more than €36 billion in financing for projects in Italy.
The European Guarantee Fund (EGF) was created by the EIB Group (EIB and EIF) with contributions from Italy and other EU Member States to protect businesses that are struggling amid the crisis caused by COVID-19. With almost €25 billion in guarantees, the fund enables the EIB and EIF to swiftly offer companies, mostly SMEs and mid-caps, access to loans, guarantees, securities and other financial instruments. The EGF forms part of the package of recovery measures put in place by the European Union, with the objective of providing a total of €540 billion to support the hardest hit sectors of the EU economy.
Diadem was founded as a spin-off of the University of Brescia (Italy) and funded by Panakes Partners. 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. AlzoSure® Predict, Diadem’s rapid, accurate and cost-effective blood-based prognostic test, will make it possible for the first time to identify patients early in the disease process, when effective interventions and better outcomes are far more feasible. It also could help make clinical trials of potential new therapies for AD more informative and efficient. The utility of the approach has been demonstrated in longitudinal 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, www.diademdx.com/.