The patent expands intellectual property coverage for the blood-based assay ahead of its planned commercial launch.
Diadem has been awarded a US patent extending intellectual property protection for its AlzoSure prognostic biomarker technology ahead of the planned commercial rollout of its AlzoSure Predict test.
The new patent broadens Diadem’s intellectual property portfolio by protecting specified methods for detecting and measuring U-p53AZ in biological samples, including blood, serum, and plasma. U-p53AZ is a conformational variant of the p53 protein associated with Alzheimer’s disease. The award builds on a US patent granted to the company in January 2019, which protects an antibody targeting an unfolded variant of the p53 protein.
Predicting Disease Progression
The AlzoSure Predict assay uses antibody technology to assess blood levels of U-p53AZ, designed to help clinicians determine the likelihood of progression to Alzheimer’s disease in individuals presenting with mild cognitive impairment. Published research indicates that the assay can predict clinical progression in Alzheimer’s disease up to six years prior to the onset of cognitive dysfunction.
In a longitudinal clinical validation study published in the Journal of Prevention of Alzheimer’s Disease, the assay achieved an area under the receiver operating characteristic curve (AUC) of more than 0.98, demonstrating performance in differentiating between patients who advanced through clinical stages of Alzheimer’s disease and 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,” says Shmuel (Sam) Agus, MD, chief medical officer of Diadem, in a release. “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.”
Regulatory Milestones and Clinical Context
AlzoSure Predict received Breakthrough Device designation from the US Food and Drug Administration (FDA) in 2022 and was granted CE-IVD certification in Europe that same year.
Diadem, a spin-out company from the University of Brescia in Italy, focuses on the development of blood-based prognostic and diagnostic technologies for neurodegenerative conditions. Alzheimer’s disease represents the most common cause of dementia, accounting for an estimated 60% to 70% of dementia cases globally.
