Alzheimer’s Progression Blood Test Gains U.S. Patent Ahead of Planned Launch

Alzheimer’s disease is the most common cause of dementia, accounting for an estimated 60–70% of cases worldwide. Its progressive effects on memory, thinking, behavior, and daily functioning underscore the importance of identifying people at risk early. To support this assessment, a newly patented blood-based prognostic test aims to help clinicians evaluate the likelihood of progression to Alzheimer’s disease, including in patients with mild cognitive impairment.

Diadem SpA (Milan, Italy) has been awarded a U.S. patent extending protection for its proprietary AlzoSure prognostic biomarker technology ahead of the planned commercial launch of the AlzoSure Predict clinical test. Building on a U.S. patent granted in January 2019, the new patent covers specified methods for detecting and measuring U-p53AZ in biological samples, including blood, serum, and plasma. The assay uses proprietary antibody technology to measure blood levels of this conformational variant of the p53 protein, which is associated with Alzheimer’s disease.

Published clinical studies have demonstrated the test’s ability to predict clinical progression in Alzheimer’s disease up to six years before the onset of dysfunction. In a longitudinal clinical validation study, AlzoSure Predict achieved an area under the receiver operating characteristic curve (AUC) of more than 0.98, distinguishing individuals who progressed through clinical stages of Alzheimer’s disease from those who did not.

“As we prepare for the commercial launch of AlzoSure Predict, securing protection for our methods of detecting U-p53AZ is an important step. 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,” said Shmuel (Sam) Agus, MD, Chief Medical Officer of Diadem.

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