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.

Parkinson's disease is the most common degenerative movement disorder and dementia with Lewy bodies (DLB) is the second commonest form of dementia after Alzheimer's disease. Parkinson's and DLB both share a common pathology, α-synuclein protein, which makes clumps called Lewy bodies in the nerve cells of the brain. The reason why Parkinson's and DLB have different symptoms is because the Lewy bodies kill nerve cells in different parts of the brain. Every year in the UK, around 20,000 people develop Parkinson's disease along with over 20,000 new cases of DLB. Diagnosis of Parkinson's or DLB can take up to 3 years and relies on clinical assessment by an expert hospital consultant. A brain scan (DaTScan) is currently the best way to help with diagnosis, but is used in only one fifth of patients. Unfortunately, DaTScan only indirectly measures disease, is only available at specialist centres, only detects established disease, and is expensive. Parkinson's and DLB patients need to be diagnosed early, so the correct treatment can be given quickly. This is especially important in DLB, where if these patients are prescribed the wrong medication, life-threatening complications can occur. Newcastle University has developed a new test called ESP - 'Extracellular Synucleinopathic Protein', for diagnosis of Parkinson's and DLB patients. ESP test can detect early disease changes in the cerebrospinal fluid (CSF - the fluid that bathes the brain) or in blood by measuring the microscopic clumps of synuclein protein found in Parkinson's and DLB. ESP has clear advantages since it could provide early, accurate, fast, minimally-invasive diagnosis, at a fraction of the cost of DaTScan. ESP could allow patients to get early and accurate diagnosis, so that they can make lifestyle adjustments, and receive correct treatment quickly. Discussions with patients, clinicians and charity organisations identified a huge unmet market need in this area, and indicated that ESP test would be a game changer for early and accurate diagnosis of these disorders. Innovate UK are supporting our new company 'ESP Diagnostics Ltd', by helping to further develop the ESP test. This will be so that the ESP test can be used for Parkinson's and DLB patients who are enrolled in clinical trials of new treatments, and eventually using ESP as part of clinical diagnosis for Parkinson's and DLB in hospitals in the UK and globally.