Respiratory leaders join forces in bid to address UK's respiratory diagnostic crisis

Cambridge, UK, November 7, 2023: TidalSense, which develops AI diagnostic and monitoring technologies for chronic obstructive pulmonary disease (COPD) and asthma, announces a project which launched in October with leading lung charity Asthma + Lung UK, international research-focused biopharmaceutical and healthcare group Chiesi Limited, Hull York Medical School and Hull University Teaching Hospitals NHS Trust, in a bid to address the current COPD diagnostic crisis.³

The organisations aim to find innovative diagnostic solutions that will help tackle the serious health problems caused by delayed diagnosis and reduced access to treatments for people with lung conditions.⁴ Over 1.4 million people are diagnosed with COPD, however, when including the undiagnosed population, estimates suggest that the total number living with COPD could be 1.9 million,⁵ with one in eight respondents to an Asthma + Lung UK survey waiting more than 10 years for a diagnosis.⁶

This project, co-developed between TidalSense, Chiesi Limited and Hull University Teaching Hospitals NHS Trust, and supported by an Asthma + Lung UK grant (£287,000) will enable the real world assessment of the clinical application of TidalSense AI diagnostic technology for COPD, using the N-Tidal handheld device.

The diagnostic test has the potential to provide someone with a diagnosis of COPD in under five minutes. It records a single minute of normal relaxed breathing via a mouthpiece, which is much easier for people to use than traditional spirometry tests as it requires less effort from the patient.⁷ As the N-Tidal device requires no specialist training or certification, it can also be administered by any healthcare professional.

In contrast, spirometry tests take around thirty minutes, and require the user to be coached and the clinician to be specifically trained.

The funding boost TidalSense has received for this project, will part-fund a study at Hull University Teaching Hospitals NHS trust, involving 1,200 people, aged 55-57, identified as having suspected COPD as part of the Lung Health Check Programme. They will assess the technology over a period of two years. Outcomes will be measured against the existing spirometry test and it is hoped it will result in the new diagnostic test being adopted across the NHS from 2025.

As part of the study, a first-of-its kind diagnostic algorithm will be built to detect changes in people with very early COPD, even if they haven't yet experienced breathing problems. COPD is an incurable lung condition, which includes emphysema or long-term bronchitis and affects around 1.4 million people in England.⁵ This supports the NHS Long Term Plan, which prioritises earlier diagnosis for people with respiratory conditions such as COPD.⁸

Hull was selected partly because of its higher levels of deprivation compared to the national average, with nearly 21% of people living in fuel poverty, compared to a national average of just over 13% (data from data.hull.gov.uk).⁹ Research, such as the recent Asthma + Lung UK Breathing Unequal report,¹⁰ demonstrates that those living in the poorest areas of England with lung conditions like COPD, have double the risk of an emergency hospital admission.

Professor Mike Crooks, a Consultant Respiratory Physician at Hull University Teaching Hospitals NHS Trust and Professor of Respiratory Medicine at Hull York Medical School, said: "This collaboration is of significant strategic importance. It enables us to work together in the realm of respiratory diagnostics, striving for improved early detection and patient outcomes. We are eagerly anticipating the progress this partnership will enable."

TidalSense is focused on developing solutions for more effective management, and faster and more accurate diagnosis of respiratory diseases. Its AI tech has been used by over 1,000 patients in clinical studies over five years.⁷

The Asthma + Lung UK grant reflects the charity's recognition of TidalSense's commitment to earlier detection of COPD and its belief that the technology could significantly change how respiratory care is managed. The importance of earlier diagnosis is included in the organisation's overall strategy for respiratory disease management and forms part of the recommendations in its recent report.¹¹ The collaboration is a major step in the ongoing focus to modernise respiratory diagnostics, whilst also underlining a shared commitment to people with lung disease.

By facilitating research into potential advances in early detection and diagnosis, the impact of TidalSense's AI diagnostic technology could be considerable.

Sarah Woolnough, CEO of Asthma + Lung UK, said: "At the moment it can take at least 30 minutes for a spirometry test to be carried out, the N-Tidal device takes under 5 minutes. The significant time saved would make the device easier for healthcare professionals to use in clinic and means that more people could get a more timely and accurate COPD diagnosis. If proven to be effective, this device could have a tangible impact on the lives of people with lung conditions. Research and innovation such as the development of new diagnostic tools has the potential to change lives and is key to helping diagnose, treat and manage lung conditions much more effectively. Lung conditions are the third biggest killer in the UK, but only receive 2% of public investment. We're fighting for increased funding for research and innovation that could transform and save millions of lives in the UK and across the world."

Tom Delahoyde, Managing Director, Chiesi Limited said: "We believe that innovation is crucial in the diagnosis of COPD, and that this collaboration is a significant step forward in investigating a promising technology. We're proud to be involved in this partnership as part of our ongoing commitment to improving patient outcomes and subsequently, their quality of life. Chiesi has been developing medicines to treat respiratory disease for more than 30 years and in that time, we know that many COPD patients face challenges with delays to diagnosis."

Dr Ameera Patel, CEO of TidalSense, added: "Partnerships like this are critical for solving big problems like the lack of simple, accurate, diagnostic testing with veracity. This collaboration will turbo-charge our efforts to gather real-world longitudinal evidence of our technology and will support us in building the next generation of early diagnostic solutions. This validation underscores our unwavering commitment to pioneering new avenues in COPD diagnosis. Speaking from personal experience having waited over a decade to be diagnosed with asthma, I know what a big impact early point-of-care diagnostic tests can have on patients, reducing prolonged anxiety, uncertainty and misdiagnosis."