Personalised diagnostics company Mologic Ltd has commenced a clinical trial to evaluate its urine-based diagnostic, HeadsUp, in monitoring pulmonary exacerbation in cystic fibrosis (CF) patients and identifying five urinary biomarkers associated with the condition. It will also validate the use of the novel point-of-care (POC) test for patients’ self-monitoring of their condition.
Patients will be recruited from the West Midlands Adult CF Centre in Birmingham, UK, where they will be under the care of the trial’s Principal Investigator, Dr Edward Nash. As one of the largest CF units in the UK, the centre currently provides care for at least 360 adults with CF.
The test is based on regularly measuring five different biomarkers in urine and using an app-imbedded algorithm to convert data to a traffic light ‘RAG’ result, indicating whether the patient is stable or in need of medical intervention. As a two-phase study, Phase 1 requires participants to perform a number of regular physiological tests and provide a daily 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 Phase 2, patients will be asked to perform the test daily to validate the selection of biomarkers and also provide information about the usability of the system.
For further information about Mologic visit www.mologic.co.uk
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