Market Overview

Mologic Commences Clinical Trial of Urine-Based Diagnostic for Cystic Fibrosis


Study will evaluate urinary biomarkers associated with onset of
pulmonary exacerbations and validate HeadsUp POC diagnostic for patient

Mologic Ltd, a developer of powerful, personalised diagnostics to
improve the lives of patients, today announced that it has commenced a
clinical trial to evaluate the Company's urine-based diagnostic,
HeadsUp, in monitoring pulmonary exacerbation in cystic fibrosis (CF)
patients. The study aims to identify five urinary biomarkers associated
with the onset of pulmonary exacerbation in adults with CF. It will also
validate the use of the novel point-of-care (POC) test for patient's
self-monitoring of their condition.

Patients will be recruited from the West Midlands Adult CF Centre,
Birmingham, UK where they are 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 as well
as providing 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.

Professor Paul Davis, Mologic cofounder and Chief Scientific Officer
: "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. 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."

Dr Edward Nash, Chief Investigator and CF Consultant: "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. 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."

To find out more about Mologic visit:


View Comments and Join the Discussion!