Clinical trial starts to evaluate and validate diagnostic test for management of cystic fibrosis

A clinical trial has been started to evaluate and validate a urine-based point of care (POC) diagnostic from Mologic, aimed at helping cystic fibrosis (CF) patients monitor and manage their condition at home.

The trial of HeadsUp will recruit patients from the West Midlands Adult CF Centre, Birmingham, UK — which is one of the largest CF units in the country. All patients will be under the care of the principal investigator, Dr Edward Nash.

All patients involved in Phase I of the trial will be required to perform a number of regular physiological tests and to provide a urine sample to Mologic. Analysis of the sample will confirm which of the urinary biomarkers already identified, are the key five associated with the onset of pulmonary exacerbation. In the second phase, patients will be asked to perform the diagnostic test daily so that the investigators can validate the selection of biomarkers and provide information about the usability of the system.

The test has been based on the regular measurement of five different biomarkers in urine and through an app-imbedded algorithm, data is converted into a traffic light ‘RAG’ result to indicate whether the patient is stable or in need of medical intervention.

“Our aim has been to develop a simple, non-invasive test that helps patients suffering from chronic lung disease to understand, monitor and manage their condition at home,” commented Professor Paul Davis, Mologic cofounder and chief scientific officer. “We have identified the biomarkers in urine that reflect critical changes in the lung and are linked with the onset of an attack. Using the techniques underlying a standard pregnancy test, the CF HeadsUp device can measure a subset of these biomarkers and transform the data into straightforward actions and medications. We now look forward to clinical trials and working with the West Midlands Adult CF Centre to build evidence and refine the tests through patient feedback.”

“For people who suffer from a chronic lung disease such as CF, there is an ever-present risk of recurrent lung attacks (exacerbations) during which every breath can be a struggle,” added Nash. “HeadsUp is non-invasive and allows frequent testing in the home, empowering patients to take control of their condition, which has the potential to reduce lung damage and avoid stays in hospital.”