COPD Exacerbation Alert for patient stratification

Our target is to develop a simple, easy to use, diagnostic system for use in the home by COPD patients to gain early warning of acute exacerbation (AECOPD) and stratify them to the most suitable and effective therapy. This will determine the use of antibiotic, anti-inflammatory or bronchodilator medication (combinations of some of these might be required). COPD is a troublesome worldwide disease with no cure, causing substantial debilitation through breathlessness that gets worse each time there is an exacerbation. Typically, the course of the disease follows periods of stability interspersed with damaging AECOPD episodes from which patients usually do not make a full recovery. Medication is needed when an exacerbation starts, rather than during the stable disease state. COPD is a large and growing world-wide problem. It is a progressively heavy burden for individual patients, carers and health services. But, despite its prevalence and impact, it is not managed well. Delays in diagnosis cause patients to miss out on prompt appropriate medication, while the lack of diagnostically guided AECOPD treatment exposes some patients to inappropriate antibiotic and/or corticosteroid therapy. Inappropriate antibiotic use should be avoided in order to minimise development of antibiotic resistance, as well as damaging side effects. There are substantial side effects of corticosteroids which also should be avoided. In July 2015, the NIHR Horizon Scanning Research & Intelligence Centre published a report on new and emerging technologies for the diagnosis and monitoring of COPD, which specifically highlighted the need for better ways to identify the cause of AECOPD, in order to guide steroid versus antibiotic treatment. The report recommended that promising technologies should be the focus of translational and clinical research funding. Moreover, the NICE Database of Uncertainties about the Effects of Treatments (DUET) highlights the use of corticosteroids and antibiotics for AECOPD as important treatment uncertainties. There is therefore a clear need for a rapid, easy and early stratification test to both identify AECOPD and to stratify sufferers into groups for treatment with antibiotics or steroids. The outcome from this project will be the development of a multiplexed, urinary biomarker diagnostic test system with integrated, personalised biomarker level interpretation algorithm for monitoring the inflammatory status of patients suffering from chronic inflammatory disease at home, with a practical simplicity and diagnostic accuracy never previously possible. This project is bold and ambitious. If successful it will have a significant positive impact on patients’ quality of life, as well as reducing health care costs, whilst representing a major business opportunity for Mologic and the UK medical diagnostics sector.