Timely diagnosis of neurodegenerative disorders through extracellular vesicle biomarker blood tests

Lewy body disease (LBD) is an umbrella term for Parkinson's disease, Parkinson's disease dementia and dementia with Lewy bodies, a spectrum of common neurodegenerative conditions. LBD may affect the patient's movement, mental and behavioural abilities, as well as many other health aspects. The condition gets gradually worse over time, and an early diagnosis is essential for lifestyle planning, preventative strategies, and effective treatment.

Currently, LBD is diagnosed by clinical assessment and complex testing, which may be invasive and inaccurate, as the symptoms of LBD may resemble other disorders. There is no single test to diagnose LBD. The diagnosis is usually slow (several months to years). This process delays the administration of appropriate therapies or poses a risk that incorrect medications are prescribed. By the time a clinical diagnosis is made it may also be too late for novel therapies to be successful as irreversible neurodegenerative damage has already happened. Early and accurate disease detection will also accelerate the development of novel drugs, as the right patients at early disease stages could be identified and enrolled into clinical trials. There is therefore a vital need for accurate tests that use minimally invasive methods, that could detect LBD early, before the symptoms develop.

ESP Diagnostics is addressing this unmet need and developing tests to diagnose LBD accurately, early, and non-invasively using blood laboratory analysis. The ESP methodology is based upon extensive research carried out within Newcastle University that resulted in the identification of LBD-specific biomarkers in extracellular vesicles (EVs). EVs are tiny sacks produced by cells and they carry biological information, including disease markers. EVs are present in various body fluids including blood. ESP Diagnostics harnesses the potential of these tiny particles circulating in the human body to develop ultra-sensitive measures that could be deployed at scale and that identify patients at the earliest stages of LBD progression, to assist clinicians with making a correct diagnosis. The ESP technology can therefore benefit the drug development process by supporting Pharma companies within clinical trials as well as pre-clinical research.

Innovate UK supported ESP Diagnostics in its early operational, commercial, and technical establishment of a cerebrospinal fluid EV-based assay for early and accurate detection of LBD. The Neurotechnology Accelerator Programme helped to further refine our commercial offering. In this project we aim to take our technology forward towards establishing methodologies for use with blood, to revolutionize early LBD diagnosis and monitoring.