News Releases

—Diadem CEO Paul Kinnon to Participate in December 5^th "Beyond Cancer Panel"—

—Diadem's AlzoSure^® Predict's Blood-Based Technology Can Identify Whether or Not Individuals Will Progress to Alzheimer's Disease (AD) Up to 6 Years Before Diagnosis and Also Identifies "Rapid Progressors" Who Will Decline to AD within 2 Years—

MILAN and NEW YORK , Dec. 4, 2023 /PRNewswire/ -- 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 Chief Executive Officer Paul Kinnon will participate in the TD Cowen Liquid Biopsy Summit, to be held at the Mandarin Oriental Hotel in New York City on December 5, 2023. Mr. Kinnon will serve as a panelist on the Beyond Cancer Panel scheduled from 2:40-3:40 pm ET that day, which will be hosted by Daniel Brennan, Cowen Managing Director, Research, Health Care - Life Science & Diagnostic Tools.

Mr. Kinnon noted, "It is gratifying to have the opportunity to participate in this TD Cowen conference highlighting critical advances in blood-based prognostic and diagnostic technologies. We are excited about the potential of AlzoSure^® Predict and other new approaches to help revolutionize the treatment of Alzheimer's and other dementias, by giving healthcare providers the tools to easily and cost-effectively determine whether patients are or are not at high risk of declining to AD in the coming years, by enabling drug developers to conduct more rapid and cost-effective clinical trials of new AD therapies and importantly, by ensuring the widest possible access as individuals and their families are able to obtain testing at home if they prefer."

About AlzoSure^® Technology

AlzoSure^® Predict is a non-invasive biomarker blood-based technology that can help identify whether or not 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. The test 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 clinical data from a longitudinal study that was the basis for AlzoSure^® Predict's Breakthrough Device designation from the U.S. Food & Drug Administration 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 technology can identify individuals 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 into AD, frontotemporal dementia, Lewy body dementia or Parkinson's disease-associated dementia. Plans for conducting clinical validation studies of AlzoSure^® Confirm are in place and are expected to get underway in the coming months, with the goal of bringing this second Liquid Biopsy test to market in the next 2-3 years.

In October, 2023, Diadem and Quest Diagnostics announced that Quest had licensed exclusive U.S. rights to the intellectual property of Diadem AlzoSure^® Predict blood-based Alzheimer's disease prognostic technology for the purpose of developing, validating and marketing a laboratory-developed test service for providers and patients in the U.S.

More than six million Americans have Alzheimer's, the most prevalent dementia, a number projected to reach 14 million by 2060. Conventional tests for Alzheimer's involve specialist-delivered PET scans and cerebral spinal fluid testing in symptomatic individuals. New blood tests offer the potential for primary care physicians as well as specialists to identify people at risk for Alzheimer's disease years before symptoms manifest.

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 now 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. Diadem is preparing for commercialisation of AlzoSure^® Predict in collaboration with global strategic partners. 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/.

SOURCE Diadem SpA