Mologic announced today that it launched a clinical trial for its Headstart system for detecting exacerbations in patients living with moderate to severe chronic obstructive pulmonary disease.
Headstart is an in vitro diagnostic self-test designed to detect five biomarkers that signal infection and inflammation in the urine of patients with COPD. The system integrates a reader and mobile phone app to capture patient-specific data and digitially transfer results to care providers for monitoring.
Bedfordshire, U.K.-based Mologic’s Cope-Wel trial is in the process of recruiting 263 patients across 10 locations in the U.K. Mologic has the goal of using the trial to expand on an earlier proof-of-concept study that successfully showed the use of Headstart as a multi-biomarker diagnostic self-test that is able to predict the early onset of COPD exacerbation up to six days prior to symptom onset.
The Cope-Wel trial is setting out to validate the machine learning algorithm and biomarkers involved with Headstart. Patients will conduct daily urine testing to establish a baseline profile before monitoring biomarkers for changes over six months.
“We are enthusiastic to bring this program to its validation study as it represents over eight years of biomarker research and product development,” Mologic co-founder & chief scientific officer Paul Davis said in a news release. “Upon its successful completion, we look forward to commercial partnership that can realize the full potential of this truly transformative approach to community-based management of patients living with COPD.”
“This simple urine test will help COPD patients distinguish the beginning of a severe lung attack from, simply, a variation in their background symptoms which will get better on their own,” added senior investigator Chris Brightling of the University of Leicester. “Identifying COPD exacerbations and intervening early with an individualized or precision medicine strategy offers patients and clinicians a very promising approach to disease management, and could be transformative for the care of people with COPD.”