Owlstone Medical said today it is launching a 1,400-patient clinical trial of its breath-based colorectal cancer diagnostic technology.
The Intercept trial aims to explore the accuracy of the U.K.-based company’s ‘breathalyzer’ test in detecting colorectal cancer at an early stage.
Owlstone’s breathalyzer uses field asymmetric ion mobility spectrometry to detect volatile organic compound metabolites in a person’s breath or bodily fluids. Volatile organic compound biomarkers can be used to non-invasively diagnose disease at a very early stage, according to the company, which could get a patient into treatment earlier than conventional diagnostic screening methods.
The system is powered by the company’s field asymmetric ion mobility spectrometer, which showed an 88% sensitivity to detecting volatile organic compound biomarkers in a pilot study, the company said.
“A combination of low compliance and low sensitivity of current tests means too many patients are diagnosed when the cancer is at an advanced stage and survival chances are very poor. Two years ago my wife died of colorectal cancer as a direct result of late diagnosis. Early detection is our greatest opportunity for saving lives when chances of survival are higher than 90% – through our InTERCEPT trial we hope to make this a reality for more patients,” Owlstone Medical CEO Billy Boyle said in prepared remarks.
“The UK has had a bowel cancer screening programme using stool testing for just over 10 years but it remains an unacceptable test to many people leading to low uptake. Whilst pilot studies have shown this will improve with the introduction of the simpler fecal immunochemical test, an alternative to stool testing would be welcome both potentially as a population screening test and as a method primary care could use to triage people more effectively to further diagnostic testing such as a colonoscopy. Detecting bowel cancer early when treatment is more effective must remain our priority so we very much look forward to seeing the results of this innovative new approach to the earlier diagnosis of bowel cancer,” Bowel Cancer UK chief exec Deborah Alsina said in a press release.
The Intercept trial is being run in collaboration with the University of Warwick, the University Hospital Coventry and Warwickshire NHS Trust, Owlstone Medical said.Ramesh Arasaradnam will serve as principal investigator for the study.
“Early detection is crucial and any measures that increase the chances of cancer being picked up as quickly as possible are to be welcomed. Patients diagnosed with bowel cancer at the earliest stage have better than 90% chance of surviving for five years, whilst for those diagnosed at the latest stage this drops to just 6.6%. However, there is considerable variation in participation levels in screening for bowel cancer cross the country, and the UK average is only 56%,” Dr Fiona Reddington of CRUK said in a prepared statement.
“There remains a clinical need for better diagnostic tests for colorectal cancer screening, prevention and early diagnosis, particularly modalities which may improve patient acceptability compared with stool testing. Owlstone Medical’s clinical study is of high relevance to the NHS and its priorities. I look forward to supporting this important study,” NCRI colorectal screening & prevention group chair Mark Hull said in a prepared release.
Last month, Owlstone Medical said it raised $11.6 million to help fund its disease breathalyzer device. The round was led by existing investors and follows an original investment of $7 million that spun the company out in June last year.
The funds will be used to commercially launch Owlstone’s breath biomaker R&D services, as the company opens a new high volume clinical facility and continues its ongoing clinical trials in lung and colon cancer diagnostics.