A new biomarker system for early diagnosis and management of Alzheimer Disease

For the first time in 20 years, new Alzheimer disease (AD) drugs are entering the market. Thus, methods that reliably detect AD early, help to diagnose patients non-invasively and predict response to these treatments will be essential in the near future. With this in mind, Pre Diagnostics has developed a novel biomarker system leveraging proprietary detection of amyloid beta (Aß) peptides. This biomarker system will be used for tests based on: 1. Saliva: A home-to-lab test for broad use in early diagnosis of AD. This test is grounded on a new analytic system for detecting AD-specific biomarkers in saliva. Due to its non-invasive nature, it will allow individuals to self-collect and send samples for clinical investigation under ambient conditions. 2. Blood (lysed cells): A less invasive alternative to the current CSF-based tests for enhanced diagnosis of AD. Pre Diagnostics is the first diagnostics company to focus on intracellular measurements of AD-specific biomarkers inside blood cells. This blood test is a first of its kind since it measures clearance products of Aß, the first hallmark of AD. This method delivers timely and relevant results for patients and practitioners. 3. Blood (live cells): A test to stratify patients to receive pioneering AD treatments. One of the main limitations of the new treatments for AD is the high incidence (up to 40% of patients) of serious adverse side effects, namely amyloid-related imaging abnormalities (ARIA). We have developed a method that can leverage our biomarker test strategy to identify patients at risk for ARIA. This will be a breakthrough invention for the AD field helping to identify the patients eligible for treatment, improving patient care and outcomes now that new treatments are finally becoming available. Thus, our novel biomarker system for AD has the potential to assist in identifying individuals in the long pre-symptomatic phase of AD, and who might benefit the most from therapeutic interventions.