Personalized diagnostics developer Mologic Ltd, Bedfordshire, UK, has commenced a clinical trial to evaluate its urine-based diagnostic, HeadsUp, for monitoring pulmonary exacerbation in patients with cystic fibrosis (CF).

The study aims to identify five urinary biomarkers associated with the onset of pulmonary exacerbation in adults with CF. It will also validate use of the novel point-of-care test, which is designed to enable patients with CF to self-monitor.

Patients will be recruited for the clinical trial from the West Midlands Adult CF Center, where they are under the care of the trial’s principal investigator, Edward Nash, MD. As one of the largest CF units in the UK, the center currently provides care for more than 350 adults with CF.

The HeadsUp test is based on regularly measuring five different biomarkers in urine and using an app-imbedded algorithm to the measurements to a traffic light red-yellow-green result, indicating whether the patient is stable or in need of medical intervention.

In phase 1 of the study, participants will perform a number of regular physiological tests, and will provide a daily urine sample to Mologic. Analysis of the samples will confirm which of the urinary biomarkers already identified are the key five associated with the onset of pulmonary exacerbation. In phase 2 of the study, patients will be asked to perform the HeadsUp test daily to validate the selection of biomarkers, and to provide information about the usability of the system.

“Our aim has been to develop a simple, noninvasive test that helps patients suffering from chronic lung disease to understand, monitor, and manage their condition at home,” says 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 Center 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,” adds Nash. “HeadsUp is noninvasive 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.”

To learn more, visit Mologic.