New patent extends protection for U-p53AZ biomarker detection methods ahead of planned commercial launch
AlzoSure® Predict will help clinicians assess the likelihood of progression to Alzheimer’s disease in patients with Mild Cognitive Impairment
MIAMI, FL and MILAN, Italy, October 19 2026
Diadem SpA, a diagnostics company developing blood-based technologies for Alzheimer’s disease and other neurodegenerative conditions, today announced that it has been awarded a US patent extending protection for its proprietary AlzoSure® prognostic biomarker technology. The patent strengthens Diadem’s intellectual property portfolio ahead of the planned commercial launch of its AlzoSure® Predict clinical test.
The AlzoSure® Predict assay uses Diadem’s proprietary antibody technology to measure blood levels of U-p53AZ, a conformational variant of the p53 protein associated with Alzheimer’s disease. Published clinical studies have demonstrated its ability to predict clinical progression in Alzheimer’s disease up to six years before onset of dysfunction. In a longitudinal clinical validation study, the test achieved an area under the receiver operating characteristic curve (AUC) of more than 0.98, demonstrating its ability to distinguish between individuals who progressed through the clinical stages of Alzheimer’s disease and those who did not (Piccirella et al, JPAD, 2022). This could help clinicians identify patients at increased risk while providing greater confidence in identifying those unlikely to progress.
“As we prepare for the commercial launch of AlzoSure® Predict, securing protection for our methods of detecting U-p53AZ is an important step,” said Shmuel (Sam) Agus, MD, Chief Medical Officer of Diadem. “The ability to predict clinical progression in Alzheimer’s disease, and to identify patients who are unlikely to progress, could help clinicians make more informed decisions about further investigation, monitoring, and care. This is particularly important as new treatment options make earlier identification of patients at risk increasingly relevant.”
The new patent builds on Diadem’s existing US patent, granted in January 2019, which protects an antibody that recognises a specific region of unfolded variant of p53. The additional patent extends protection to specified methods of detecting and measuring the protein in biological samples, including blood, serum and plasma.
AlzoSure® Predict received Breakthrough Device designation from the US Food and Drug Administration (FDA) in 2022 and was granted CE-IVD certification in Europe the same year.
About Alzheimer’s disease
Alzheimer’s disease is the most common cause of dementia, accounting for an estimated 60–70% of cases worldwide. It is a progressive neurodegenerative disease that affects memory, thinking, behaviour, and the ability to carry out everyday activities. Early identification of individuals at increased risk of progression could support timely clinical assessment and decisions about treatment and care.
About Diadem
View full-size imageDiadem was founded as a spin-out of the University of Brescia, Italy. The company is developing blood-based prognostic and diagnostic technologies for Alzheimer’s disease and other neurodegenerative conditions. Its lead product, AlzoSure® Predict, is designed to identify individuals at increased risk of progressing to Alzheimer’s disease before clinical diagnosis.
Media contact
Exec Admin to CEO: execadmin@diademdx.com