PreADx is a dynamic test that measures the ongoing clearance of Abeta trough the detection of split products from the Abeta peptide. The first product, the X-34 abeta monocyte assay, has been CE marked, and is also ready for use as a Research Use Only product.
Alzheimer’s disease (AD) is a leading cause of dementia and poses a dramatic global health burden. More than 50 million people are currently living with dementia globally, with a projected increase to 152 million by 2050. The total worldwide cost of dementia is estimated to be US $1 trillion in 2019, and estimated to double by 20302. Although there are over 130 therapeutic candidates currently in pipeline, therapies under development have so far been failing. This in large part due to lack of understanding of the underlying disease mechanisms and the lack of optimal diagnostics tools that would enable for the necessary early diagnosis required for early intervention options. The recent FDA approval of Biogen’s immunotherapy and with four new immunotherapies with FDA Fast Track Designation, including Roche, Lilly and Eisai, focus is again moving towards early diagnosis and tools for early detection.
Our newest project entails the use of PreADx for personalized treatment of Alzheimer patient’s that are eligible for these new immunotherapies. The immunotherapies show promising clinical results, but between 10-40% of patients on high-dose treatment suffered from the serious adverse side event of “ARIA”, Amyloid-related imaging abnormalities, or brain hemmeraging. There is currently no available biomarker to detect patients at risk for ARIA, or monitor ongoing treatment for these patients.