Diadem Awarded Patent in China for Its AlzoSure® Prognostic Biomarker Technology that Accurately Predicts Progression to Alzheimer’s Disease
—AlzoSure® Accurately Predicts Progression to Alzheimer’s Disease Up to Six Years Earlier than Current Diagnostic Methods—
—Soon-to-Be-Released Data Shows that AlzoSure Predict Can Also Accurately Classify Patients with Mild Cognitive Impairment or Related Conditions with AUC of 95%
The Diadem AlzoSure Predict assay uses a proprietary antibody to measure blood levels of a conformational variant of the p53 protein that has been implicated in the pathogenesis of AD. Multiple studies show that this p53 variant has utility as a predictive biomarker to identify individuals likely to progress to AD up to six or seven years before symptoms appear.
“China has about 10 million patients suffering from Alzheimer’s disease, the highest number of any country in the world, in addition to more than 30 million people afflicted with mild cognitive impairment,” noted Paul Kinnon, CEO of Diadem. “According to the Chinese Geriatrics Society, the number of Alzheimer's patients in China is expected to exceed 40 million by 2050. Given the enormous population affected, we believe that our simple and accurate blood-based prognostic test that can identify people early in the disease process would be of great value in China. Early identification has never been more important as interventions to slow or halt disease progression are now becoming available. We are currently in discussions with a number of potential commercialization partners in China.”
Mr. Kinnon added, “We have reported multiple studies this year showing that AlzoSure Predict accurately identifies individuals who will progress to AD at least six years or more before definitive diagnosis is feasible. We expect to be publishing additional validating data in the coming weeks that demonstrates that our biomarker test can accurately predict progression to AD up to six years before diagnosis with an AUC of >90%. Additionally, these new data show that AlzoSure Predict can accurately classify early disease status with an AUC of 95%, distinguishing whether individuals are appropriately classified as having Subjective Memory Complaints (SMC) or Mild Cognitive Impairment (MCI). We look forward to reporting on these data in the near future.”
Diadem is developing the AlzoSure assay as a non-invasive plasma-based biomarker test to accurately predict the probability that individuals who are asymptomatic or have mild cognitive impairment will progress to Alzheimer’s dementia. The company’s technology uses an analytical method that includes a proprietary antibody developed by Diadem designed to bind to the U-p53AZ conformational variant protein and its target sequences. Diadem is conducting further validation studies with additional results expected shortly. The company plans to initiate a global launch in collaboration with strategic partners within the next 12 months.
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.
Diadem was founded as a spin-off 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 early clinical studies. Additional retrospective and prospective clinical trials are ongoing and planned to further validate clinical claims and support widespread adoption and use. 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 rapid commercialization of its initial Alzheimer’s prognostic via a global launch in collaboration with strategic partners.