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Asthma UK and Innovate UK fund initiative to develop new tests for asthma diagnosis

Dr Clare Murray, NIHR Manchester BRC Asthma Programme Associate Lead and Clinical Senior Lecturer at the University of Manchester is leading a research project between the University of Manchester and Owlstone Medical to develop new tests for asthma diagnosis. The project will look at the small airways in the lungs to assess treatment response and aims to reduce the number of people that are wrongly diagnosed and are taking unnecessary medication.

Under a joint Asthma UK and Innovate UK funding initiative, which seeks to broker research collaborations between academia and UK industry to develop new tools that can accurately diagnose asthma and its subtypes, the University of Manchester will receive £249,950 to fund a three-year study. Within the study, Owlstone Medical will be deploying its novel Breath Biopsy® platform to collect breath samples from asthmatic patients and healthy controls, which will then be analyzed to identify breath-based biomarkers for the definitive diagnosis of asthma and to guide effective front-end treatment decisions. This research will be embedded within RADicA (Rapid Access Diagnostics for Asthma study), an NIHR Manchester Biomedical Research Centre (BRC) funded study of asthma diagnosis.

Although asthma is an extremely common condition, diagnosis can be challenging as there is presently no reliable and definitive diagnostic test available. Current guidelines recommend asthma is diagnosed based on clinical judgement, combining the presence of symptoms suggestive of asthma with results in the most commonly used pulmonary tests (spirometry, peak flow variability, bronchodilator reversibility) and the fraction of exhaled nitric oxide (FENO), which focus primarily on the large airways. While these tests have been used for many years, evidence shows that they are poor at diagnosing asthma because asthma affects both large and small airways, and it is now recognized that the small airways are just as important to establish a clear diagnosis.

Breath is emerging as a highly promising way to directly measure metabolites reflecting underlying disease activity. This non-invasive approach can provide important information relating to both small and large airway function that can offer a “window” into the lung health of an individual, including identification and monitoring of disease.

The project has several aims, including using breath-based biomarkers and measures of small airway function to: enable the rapid, accurate and low-cost diagnosis and monitoring of asthma; to better classify different forms of asthma, their progression, and effect on airway inflammation; and to predict early if someone is likely to respond to inhaled corticosteroid (ICS) treatment. Additionally, by using the data collected in the NIHR Manchester BRC funded RADicA study, the project will compare the performance and clinical utility of these approaches to the existing large airway tests.

Dr Clare Murray, Clinical Senior Lecturer at the University of Manchester and NIHR Manchester BRC Asthma Programme Associate Lead:

The treatment of asthma remains very challenging, not least because it is better considered a syndrome with many underlying causes, each of which may differ by optimal treatment. The emergence of new devices that enable biomarkers to be detected on breath however, has the potential to revolutionize asthma diagnosis.

Billy Boyle, co-founder and CEO at Owlstone Medical, commented: “Our partnership with the University of Manchester builds on prior work Owlstone Medical has done as part of the STRATA trial. Also funded and supported by Asthma UK and Innovate UK, STRATA was designed to conduct research into the use of VOCs in patients’ exhaled breath as a way to select the best individualized treatment. We remain committed to deploying Breath Biopsy to help the 5.4 million people with asthma in the UK and estimated 339 million worldwide who could benefit from personalized healthcare.”

Dr Erika Kennington, Head of Research at Asthma UK, said: “We are delighted to partner with Innovate UK to joint-fund this project. Diagnosing asthma can be extremely difficult and this is mainly because there is a lack of definitive diagnostic tools. This research provides an exciting opportunity to improve the accuracy of asthma diagnosis, meaning people with asthma can then get faster access to treatments and care.”

Dr Kath Mackay, Interim Director – Ageing Society, Health & Nutrition at Innovate UK said: “Many of us either are or know asthma sufferers, so are only too aware of the pressing need for better diagnosis and improved, personalized treatments. This new funding will allow innovative businesses to work hand-in-hand with the very best researchers to bring forward these much-needed breakthroughs. By choosing to work in partnership with leading charities, such as Asthma UK we can connect businesses to the resources that the charities may have. This can be access to patients, new ideas and the ability to generate real world evidence.”