Mologic Launches Clinical Trial for Validation of Point-of-Care COPD Exacerbation Alert System

Mologic Ltd., a developer of lateral flow and rapid diagnostic technologies, has started a major clinical trial to validate the company’s urine-based multi-biomarker self-test, Headstart, for the early detection of exacerbations in patients living with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Supported by a wide consortium of clinical experts, the observational trial known as COPE-WEL has recently started recruitment of 263 patients across 10 centres in the United Kingdom.
 
Headstart is an in-vitro diagnostic self-test that detects five biomarkers indicative of infection and inflammation in the urine of COPD patients. The COPE-WEL trial expands on a previous proof-of-concept study that successfully demonstrated the use of Headstart as a multi-biomarker diagnostic self-test with the ability to predict the early onset of a COPD exacerbation up to six days prior to symptom onset, or up to nine days prior for clinical diagnosis by a healthcare provider. 
 
The COPE-WEL trial will clinically validate the machine learning algorithm and five selected biomarkers integrated into the Headstart system, with patients conducting daily urine testing to establish a baseline biomarker profile and monitor these biomarkers for changes over a period of six months. The Headstart system is designed for home monitoring and integrates a simple, easy to use diagnostic with a reader and mobile phone app to capture patient-specific health data, which are digitally transferred to care providers for monitoring and provide patients early warning of an exacerbation event, prior to clinical signs. As part of Mologic’s flagship respiratory program, validation of the Headstart system will provide patients with a transformative approach to tailoring remote disease management and early treatment.
 
COPD is a progressive life-threatening lung disease that causes breathlessness and predisposes patients to frequent attacks resulting in serious illness, hospitalisation and even death. Symptoms often don’t appear until significant lung damage has already occurred, usually worsening over time. If exacerbations can be identified before the symptoms appear, they can be dealt with earlier, limiting their effect and potential consequences. Globally it is estimated that 251 million people are living with the condition and more than 3 million associated deaths each year which are projected to increase by more than 30 percent in the next 10 years (WHO Fact Sheet, Nov 2017; WHO, 2019). 
 
Clinical partners in the trial include Professor Chris Brightling, National Institute for Health Research (NIHR) Senior Research Fellow and clinical professor in respiratory medicine at the University of Leicester, who is leading the clinical study at the NIHR Leicester Biomedical Research Centre, based at Glenfield Hospital, with Professor Keir Lewis, chair in respiratory medicine Swansea University and R&D director, Hywel Dda University Health Board, Wales. 
 
Professor Paul Davis, chief scientific officer and co-founder, Mologic, said: “We are enthusiastic to bring this program to its validation study as it represents over eight years of biomarker research and product development. 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.”
 
Professor Chris Brightling, NIHR senior investigator, University of Leicester, commented: “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. Identifying COPD exacerbations and intervening early with an individualised 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.”
 
Lewis added: “COPD is now the third most common cause of death worldwide. Sufferers experience daily breathlessness and recurrent lung attacks often needing admission to hospital. Headstart is based on a urine test and applies state-of-the-art biomarker measurement with app technology to place a simple kit in the patient’s home. This puts the patient at the heart of their care and we hope early warning of worsening COPD could stop attacks before they take hold. I am delighted to be continuing work with Mologic on this ground-breaking project as I believe Headstart offers a fabulous opportunity to impact this devastating illness.”
 
The development of Headstart is co-funded by the United Kingdom’s innovation agency, Innovate UK, through its SBRI Healthcare initiative.
 
Mologic develops advanced lateral flow and rapid diagnostic technologies. Leveraging its core technology platforms, the company works with global organizations, researchers, and clinicians to help them deliver fast, reliable, and accurate diagnosis at the point-of-care. Mologic’s founder (Paul Davis) was the originator of the Clearblue pregnancy test that was launched in 1988 as the world’s first commercial application of lateral flow technology. The creativity, insight and knowledge that led to that ground-breaking invention has guided Mologic since its formation in 2003.
 
Mologic offers technology and scientific research expertise for contract research and development, alongside a portfolio of device and reagent products for clinical and commercial applications. The company also helps organizations to scale-up manufacturing from initial prototyping through low to mid-scale production. Mologic’s science has broad application across markets and disease states where rapid, accurate point-of-care testing can help make a difference in patient care and patient outcomes. Clients include the Bill & Melinda Gates Foundation, where Mologic is leveraging core technology through its Centre for Advanced Rapid Diagnostics (CARD) to develop the next-generation of ultra-sensitive point-of-care diagnostics, which are easy to use and low cost to manufacture—critical to the success of many global health programs.
 
The company is actively seeking strategic partners for its internal pipeline of respiratory, infection, infectious disease, and women’s health diagnostics. Mologic is headquartered in Bedford in the United Kingdom and has a U.S. subsidiary in the greater Boston area.