—Have Identified Specific Post Translational Modifications of a Conformational Variant of p53 that Represent Unique Signatures Indicating Whether or Not Individuals Have Alzheimer’s Disease—
—Study Data Also Suggest AlzoSure® Confirm Can Distinguish Alzheimer’s Disease from Other Dementias—

Milan, ITALY and Barcelona, SPAIN – March 22, 2022 – Diadem srl, a company developing blood-based tests for the early prediction and diagnosis of Alzheimer’s disease (AD), today announced that it presented data at the AD/PD™ 2022 International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD22) showing that its new AlzoSure® Confirm blood test can accurately identify patients with Alzheimer’s disease. The presentation, “ First Non-Invasive Blood-Based Test for the Diagnosis of Alzheimer’s Disease and Other Dementias, ” was delivered by Diadem chief executive officer Paul Kinnon at the conference in Barcelona, Spain on March 19, 2022.

AlzoSure® Confirm has been developed on the same technology platform that underlies AlzoSure® Predict, Diadem’s prognostic blood test that can accurately predict whether or not an individual with early cognitive changes will progress to Alzheimer’s disease up to six years before the condition is fully manifested. AlzoSure® Predict has been designated a Breakthrough Device by the US Food & Drug Administration and recently obtained a CE-IVD mark allowing it to be marketed in the UK and the European Union.

The new assay is based on the same U-p53AZ integrative biomarker—a conformational variant of p53—which has been associated with the pathogenesis of AD in more than 400 studies, with documented interactions with amyloid, tau and other factors associated with patients’ progression to AD. Diadem’s patented technology has been developed using its U-p53AZ platform.

In the study presented at AD/PD22, Diadem researchers used a subset of samples from a longitudinal database of almost 500 patients exhibiting different stages of cognitive decline to investigate the full sequence of post-translational modifications (PTMs) of U-p53AZ over the course of the continuum that culminates in Alzheimer’s disease. They discovered that specific PTM “fingerprints,” or signatures, were characteristic of different stages of the progression to AD. AlzoSure® Confirm uses the PTM signature characterizing full- fledged Alzheimer’s disease to provide a blood-based biomarker test potentially capable of diagnosing AD. In the early clinical validation data Diadem presented at AD/PD22, this PTM signature was able to reliably detect patients with AD and to distinguish them from patients with other dementias.

At Diadem, we are committed to developing widely accessible prognostic and diagnostic blood tests capable of accurately identifying individuals who either have Alzheimer’s disease or who will progress to AD in the coming years,” said Mr. Kinnon. “Our AlzoSure® Predict prognostic blood test has already been validated in large longitudinal clinical studies and will be available in the EU later this year. We are also very excited about our new AlzoSure® Confirm test, which has the potential to accurately and specifically diagnose Alzheimer’s disease using a simple blood test. The lack of timely, accurate and affordable diagnostics has hindered progress in developing more effective treatment options for AD patients, and we look forward to working with a variety of partners to produce and report more confirmatory data on AlzoSure® Confirm.”

A copy of the Diadem AD/PD22 presentation is available via the Diadem Click Here

About Alzheimer’s Disease
There are about 50 million people suffering from dementia worldwide. Alzheimer’s disease is the most common form and accounts for 60-70% of cases. At present there are no disease modifying treatments for Alzheimer’s, and therapies to treat symptoms are limited. There are about 10 million new cases per year, and the incidence is rising rapidly as the population ages. The current total cost of care is enormous–estimated at $1 trillion in the U.S. annually and expected to double by 2030. Currently, diagnosis of Alzheimer’s disease is slow, inconclusive, invasive and expensive. Development of effective therapies for Alzheimer’s has been hindered by the lack of accurate and cost-effective prognostic and diagnostic methods. 

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 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. Diadem’s rapid, accurate and cost-effective blood-based prognostic test makes it possible for the first time to identify patients early in the disease process, when effective interventions and better outcomes are far more feasible. The utility of the approach has been demonstrated in longitudinal clinical studies that were the basis for awarding CE-IVD marking in the EU and a Breakthrough Device designation in the US. Additional retrospective and prospective clinical trials are ongoing to further validate clinical claims and support widespread adoption and use. Diadem is also developing AlzoSure® Confirm, a blood-based diagnostic test for AD that has shown promising results in early studies. 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 commercialization of AlzoSure® Predict in collaboration with global strategic partners. For more information, visit www.diademdx.com/.