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Case study: Development of a diagnostic for acute exacerbation of COPD

The NIHR works in partnership with medical device, digital technology and diagnostic companies (collectively known as MedTech) to help them successfully translate innovative ideas into the clinical setting.

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The Innovation

Mologic Ltd, a UK-based SME, has invented a urine-based test system ‘HeadStart’, designed to enable chronic obstructive pulmonary disease (COPD) patients to monitor their
disease status at home for early indications of exacerbation. A second, related test system, called ‘RightStart’ is designed to be used by healthcare professionals to stratify
exacerbating patients with regard to which medication should be used – antibiotics or anti-inflammatory treatment.

The Challenge

The symptoms of a developing COPD exacerbation are often unclear and patients’ ability to recognise them can be highly variable. When exacerbations occur, many patients go directly to A&E while others notice changed symptoms for some days before taking action, increasing the likelihood of an eventual A&E visit. Early identification of exacerbations will enable clinicians to begin effective treatment in the community which may help reduce the number of A&E visits. Confident use of the right medication will provide better outcomes, cost savings and minimised risk of antibiotic resistance.

The Research

The company gained funding from the Small Business Research Initiative (SBRI) and Health Enterprise East to provide early health economics data on HeadStart and RightStart,
and to gather further evidence of efficacy. The health economics analysis was carried out with support from the Newcastle and Oxford NIHR MedTech and In vitro diagnostics Co-operatives (MICs), The funding allowed the company to refine the selection of candidate biomarkers, conduct some preliminary validation work for the product and enabled them to carry out initial evaluations with an early version of HeadStart with 10 patients. Working with the Oxford and Newcastle MICs provided the company with access to MedTech expertise and support in developing an early adoption plan. Within this phase Mologic also collaborated with the University of Leicester to carry out usability studies of the early version of HeadStart.

In collaboration with the NIHR MICs, Mologic prepared a successful application for an Innovate UK Stratified medicine SBRI Phase 2 contract to further develop HeadStart and
RightStart to provide robust evidence on clinical utility and cost-effectiveness of the integrated tests. This will enable Mologic to get HeadStart through development to CE-marking and early adoption. As part of this stage Mologic partnered with Bond Digital Health in order to develop the accompanying HeadStart app.

Mologic also gained critically important early advice and guidance from the NIHR Respiratory Translational Research Collaboration, involving access to expert COPD researchers
and opportunities to test the principles behind the predictive biomarker panel used in the HeadStart system. Through these connections, Mologic was provided with highly valuable COPD patient samples for essential proof-of-principle studies.

The Impact

Ultimately, it is the intention to use the HeadStart test to empower COPD patients to gain better understanding and control of their disease, thereby reducing the demand for urgent clinical care and minimising the need for attendance at A&E. Through the associated RightStart test, inappropriate use of antibiotics will be minimised and patients will have the benefit of starting on the right medication every time they experience an exacerbation.