UK-based personalised diagnostics developer Mologic has launched a clinical trial to investigate the ability of its HeadsUp diagnostic to monitor the pulmonary exacerbation associated with cystic fibrosis (CF).
HeadsUp is a urine-based point-of-care (POC) test being developed for the routine measurement of five biomarkers in urine.
The diagnostic uses an in-app algorithm to convert the analysed data into a traffic light ‘RAG’ result, which indicates the patient’s condition and any requirement for medical intervention.
During the two-phase trial, investigators will work towards identifying five urinary biomarkers related to the onset of pulmonary exacerbation in adults suffering from CF.
In addition, the trial aims to validate the use of the test for self-monitoring by patients. Patient enrolment for the study will be carried out from the West Midlands Adult CF Centre in Birmingham, UK.
Mologic co-founder and chief scientific officer Paul Davis said: “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.
“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.”
Phase I of the trial will involve various regular physiological tests and daily urine sample collection.
These samples will be analysed to confirm the presence of already detected biomarkers associated with the onset of the pulmonary condition, and to identify five key compounds amongst them.
In Phase II, patients have to perform the test daily to validate the selected biomarkers as well as to offer insights on the usability of the system.