Diadem Appoints Michael Rasche as Chief Executive Officer

Brings International Perspective and Extensive Experience Across Multiple Life Sciences Sectors to Advance Diadem’s Pioneering Prognostic Technology for the Early Detection of Alzheimer’s Disease

Michael Rasche

MILAN, July 10, 2024 (GLOBE NEWSWIRE) -- Diadem SpA, (Diadem), a company developing one of the first blood-based tests for the early and accurate prediction of clinical progression to Alzheimer’s disease (AD), today announced that Michael Rasche has been named Chief Executive Officer (CEO) and a member of the Board of Directors. Mr. Rasche brings Diadem more than three decades of experience in driving life sciences innovations to commercial success across Europe and the Americas. The company also announced that former CEO Paul Kinnon will continue to serve on the Diadem SpA board and has been named Chairman of Diadem US, Inc.

Dr. Gerald Möller, Chair of Diadem’s Board of Directors, commented, “I am delighted that Michael will be leading Diadem at this exciting time for the company. Michael’s broad experience spans leadership roles in market development, sales and general management in our industry. His drive, skills and commitment have enabled him to successfully commercialize multiple innovative products. The growing number of therapeutic options for AD highlight the importance of identifying and monitoring Alzheimer’s patients early, with growing evidence that early interventions can slow disease progression. Our AlzoSure^® prognostic test can accurately identify individuals who will progress to AD years before the disease manifests. With Michael on board and Paul´s continued activities we will be optimally positioned for the upcoming growth phase of Diadem.

Mr. Rasche noted, “I am thrilled at the opportunity to lead Diadem as we move to rapidly commercialize the AlzoSure^® products—a truly innovative approach to improving the management of Alzheimer’s disease. Diadem has already amassed an impressive amount of clinical data demonstrating the accuracy and utility of AlzoSure^® as a prognostic test for AD, and our research suggests additional applications as well. I look forward to working with our team and our partners to advance our business and ensure that the benefits of AlzoSure^® are widely available to relevant stakeholders around the globe.”

Michael Rasche has more than 30 years of leadership experience in high growth international healthcare and life sciences firms across Europe and the Americas. Most recently, he was Chief Commercial Officer at transformational diagnostics firm miDiagnostics. Previously Rasche was President and General Manager of International Business at Metabolon, where he oversaw operations and commercial activities during a period of very rapid growth. At Definiens, an AstraZeneca company, Rasche helped expand the business as Chief Commercial Officer, achieving 50% growth and setting the stage for major partnering agreements. He has also held leadership positions with Ayoxxa, Dako (now part of Agilent), Roche and Bayer Diagnostics.

Diadem’s AlzoSure^® Predict is a non-invasive biomarker blood test that can identify with high accuracy whether individuals over the age of 50 will experience significant cognitive decline due to Alzheimer’s disease up to six years before the onset of symptoms. Its utility is supported by clinical data from a large longitudinal study that was the basis for AlzoSure^® Predict’s CE-IVD marking clearance and a Breakthrough Device designation from the U.S. Food & Drug Administration. Diadem has formed a strategic collaboration granting Quest Diagnostics exclusive U.S. rights to the intellectual property of the AlzoSure^® Predict mass spectrometry assay for the purpose of developing, validating and marketing a laboratory-developed test service for U.S. providers and patients.

About AlzoSure^® Technology
AlzoSure^® Predict uses a proprietary antibody (U-p53^AZ) to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD. The utility of AlzoSure^® Predict is supported by a large body of clinical data, including data from a longitudinal study that was the basis for AlzoSure^® Predict’s Breakthrough Device designation from the U.S. FDA and its CE-IVD marking in the E.U. AlzoSure^® Predict requires only 1mL of blood to detect the risk of Alzheimer’s disease at the asymptomatic and early symptomatic stage. In addition, the AlzoSure^® Predict products can identify “rapid progressors” at high risk of progressing to Alzheimer’s disease within two years. Diadem is also developing AlzoSure^® Confirm for the differential diagnosis of Alzheimer’s disease and other dementias. AlzoSure^® Confirm is a blood-based assay that uses a different set of protein fingerprints to measure levels of the unfolded p53 protein in order to distinguish between and predict whether or not individuals will decline to AD, frontotemporal dementia, Lewy body dementia or Parkinson’s disease-associated dementia. Clinical validation studies are underway.

About Diadem
Diadem was founded as a spin-out 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 has contributed to the lack of effective treatments for this devastating condition. As a result, patients have not been diagnosed until late in the illness, when effective treatment is less feasible. Diadem’s rapid, accurate and cost-effective AlzoSure^® Predict blood-based prognostic test makes it possible to identify patients early in the disease process, when effective interventions and better outcomes are potentially achievable. The utility of the approach has been demonstrated in longitudinal clinical studies that were the basis for awarding CE-IVD marking in the E.U. and a Breakthrough Device designation in the U.S. Additional retrospective and prospective clinical trials are ongoing to further validate clinical claims and support adoption and use. The company is also developing AlzoSure^® Confirm, a blood-based diagnostic test for AD that has shown promising results in early studies. For more information, visit diademdx.com.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8e5a1c58-4816-4ab5-a4d5-f5a48efcea04

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