With the support of the Swansea team, Glyconics have been awarded a Small Business Research Initiative for Healthcare (SBRI Healthcare) development contract for an initial feasibility study to assess the clinical performance of the miniaturised Fourier transform infrared (FTIR) device.

SBRI Healthcare is an NHS England initiative, championed by the newly formed Academic Health Science Networks (AHSNs), who aim to promote UK economic growth whilst addressing unmet health needs and enhancing the take up of known best practice.

Chronic Obstructive Pulmonary Disease, or COPD, is a common, progressively disabling disease and a major health burden worldwide. It is not a single disease, but an umbrella term used to describe a spectrum of chronic lung diseases that cause limitations in lung airflow, and includes chronic bronchitis and emphysema.  

Within the next seven years, COPD is predicted to be the third leading cause of death worldwide and the fifth most common cause of disability in the world.

The technology, which has been developed by Dr Paul Lewis of Swansea University’s Centre for NanoHealth  (CNH), will be commercialised by Glyconics with Dr Lewis who will be responsible for co-ordinating all technology evaluation, development and clinical programmes.

Dr Berwyn Clarke, CEO of Glyconics Ltd, said: “In the UK, COPD is estimated to affect some six million people causing 24 million working days to be lost, at a cost of nearly £4 billion per year from reduced productivity and is responsible for more than 25,000 deaths annually.

“As the disease progresses patients develop increasingly frequent and severe exacerbations and have an increased rate of hospitalisation. This hand-held technology not only allows more accurate diagnosis of COPD at the point-of-care but is also able to detect the onset of exacerbations very early. This is extremely important to the NHS since exacerbations are a major factor in the £1 billion per annum cost of managing COPD.”

COPD is currently an under-diagnosed condition, with some 50 per cent of sufferers unaware of their diagnosis. Poor recognition and treatment of respiratory failure increases the risk of mortality; there is thus a currently un-met need to improve diagnostic rates, reduce the burden of exacerbations and prevent the need for hospital admissions.

However, there is currently no existing gold-standard or state-of-the-art technology available to identify early markers of disease exacerbation in COPD.

Dr Lewis has identified the potential of using Fourier transform infrared (FTIR) spectroscopy as a rapid, cost-effective and non-invasive technology for COPD diagnosis and prediction of exacerbation.

However, current FTIR equipment is prohibitively expensive, restricting any widespread and cost-effective uptake of the methodology. The recent availability of miniaturised components for low cost instruments now offers the opportunity to transform clinical accessibility. 

Dr Lewis’ team are a leading laboratory in the study of infrared spectroscopy for analysis of mucin structure and glycosylation relevant to respiratory disease.  They lead the Medlung UK multi-centre trial for respiratory diagnostics and have identified patterns in the sputum of patients which are unique to COPD and which have been filed for patents.  Further research into other specific respiratory disease patterns are already underway and show promising potential.

The development contract from SBRI Healthcare will enable the implementation of a feasibility study to explore the potential to provide a technology-based solution that can be simply introduced as a means to identify disease severity, disease progression and an early indication of exacerbation.

Dr Lewis said: “Utilising infrared COPD biomarkers and modern electronic and optical components, the ultimate goal is to develop a hand-held, miniaturised FTIR device for easy detection and monitoring by healthcare workers at the point-of-care.

“This Phase 1 study will hopefully prepare the ground for a full Phase 2 project, through evaluation of the technical, clinical, regulatory, and commercial viability of the technology, and the preparation of a full implementation and commercial strategy.”

Pictures:

Dr Paul Lewis of Swansea University’s Centre for NanoHealth (CNH) with the miniaturised Fourier transform infrared (FTIR) device.

A picture of Sputum taken with the Centre for NanoHealth’s Scanning Electron Microscope (SEM).