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.”
