Owlstone Medical, Cambridge, UK, has commenced a 1,400-patient clinical trial for the early detection of colorectal cancer using the company’s microchip field asymmetric ion mobility spectrometer (FAIMS) technology. Known as Intercept, the trial aims to evaluate the accuracy of Owlstone Medical’s noninvasive, high-compliance breath (and urine) test for the detection of colorectal cancer at an early stage, when patient survival rates are at their highest.
The trial follows a successful pilot study using Owlstone Medical’s FAIMS platform technology, which showed sensitivity of 88% in detecting volatile organic compound (VOC) biomarkers for colorectal cancer. In addition, the pilot study showed sensitivity of 62% for detection of advanced adenomas, a precancerous stage of colorectal cancer, representing a substantial increase in the rate of detection compared with the fecal occult blood tests used currently within the UK’s National Health Service bowel cancer screening program.
“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,” says Billy Boyle, cofounder and CEO of Owlstone Medical. “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.”
The trial is being run in collaboration with the University of Warwick and the University Hospital Coventry and Warwickshire NHS Trust, with consultant gastroenterologist Ramesh P. Arasaradnam, MBBcH, PhD, as principal investigator of the study. The work has received widespread support from research organizations and charities including Bowel Cancer UK, Cancer Research UK, the National Cancer Registry Ireland colorectal screening and prevention subgroup, and the NIRI Clinical Research Network.
“The UK has had a bowel cancer screening program using stool testing for just over 10 years, but it remains an unacceptable test to many people, leading to low uptake,” says Deborah Alsina MBE, chief executive of Bowel Cancer UK. “While 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,” adds Alsina.
For more information, visit Owlstone Medical.