UK diagnostics group Owlstone Medical has kicked off a 1,400 patient clinical trial assessing the potential of its FAIMS (Field Asymmetric Ion Mobility Spectrometer) technology in the early detection of colorectal cancer, which it claims to be the world’s largest breath-based study into the disease.
The InTERCEPT trial aims to evaluate the accuracy of Owlstone’s non-invasive, high-compliance breath (and urine) test in diagnosing colorectal cancer at an early stage, in the hope of improving survival rates from the disease, which is the second most common cancer killer worldwide with 215,000 deaths every year.
Current faecal screening tests have a low compliance rate which, combined with relatively low test sensitivity particularly in early disease stages, “means that too many patients are diagnosed with late stage disease, leading to poor patient outcomes,” according to the firm.
The trial – which is being run in collaboration with the University of Warwick and the University Hospital Coventry and Warwickshire NHS Trust with consultant gastroenterologist Professor Ramesh Arasaradnam as Principal Investigator – follows a successful pilot study using Owlstone’s FAIMS platform technology, which showed sensitivity of 88 percent in detecting Volatile Organic Compound (VOC) biomarkers for the disease.
It also showed sensitivity of 62 percent for detection of advanced adenomas, a pre-cancerous stage of colorectal cancer, representing a substantial increase in the rate of detection versus the faecal occult blood tests currently within the NHS bowel cancer screening programme.
“Early detection is crucial and any measures that increase the chances of cancer being picked up as quickly as possible are to be welcomed,” said Dr Fiona Reddington, head of Population, Prevention and Behavioural Research at Cancer Research UK, commenting on the trial.
“Patients diagnosed with bowel cancer at the earliest stage have better than 90 percent chance of surviving for five years, whilst for those diagnosed at the latest stage this drops to just 6.6 percent. However, there is considerable variation in participation levels in screening for bowel cancer cross the country, and the UK average is only 56 percent.”
Professor Mark Hull, consultant gastroenterologist and chair of the NCRI colorectal screening & prevention sub-group, also highlighted the “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”.
