Mologic, an U.K.-based company developing personalized diagnostic devices, announced the beginning of a Phase 1/2 clinical trial to test its urine-based diagnostic tool, HeadsUp, to monitor pulmonary exacerbations in patients with cystic fibrosis (CF).
The study is designed to identify biomarkers, present in urine of CF adult patients, that are linked to the worsening of lung function (pulmonary exacerbation). The trial also will validate the use of the ready-to-use test that allows patients to self-monitor their condition.
“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,” Edward Nash, MD, the study’s principal investigator, said in a press release.
“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,” Nash said.
The HeadsUp test measures five different biomarkers in urine based on an app-imbedded algorithm that converts data to a so-called RAG file — a color-based file (red, amber and green) — that indicates whether the patient is stable or in need of medical intervention.
The study will be divided into Phases, 1 and 2. In the first part, patients will perform a number of physiological tests and will provide a daily urine sample to Mologic, so the company can identify which top five biomarkers, of those already identified, are associated with the onset of exacerbations.
Part 2 of the study will validate the results of the first part, in which patients will be asked to perform the test daily at home and to provide feedback about the usability of the device.
Participants will be recruited at the West Midlands Adult CF Centre, in Birmingham, U.K., where they are being followed by Nash. The center is one of the largest CF units in the U.K., with about 360 adults being treated at its facilities.
“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,” said Paul Davis, co-founder and chief scientific officer of Mologic.
“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 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,” Davis concluded.