Pilot study demonstrates FAIMS technology can detect patients inadequately prepped prior to colonoscopy with 100% sensitivity
Owlstone Medical, a diagnostics company developing a breathalyzer for disease, has entered into a collaboration with Mayo Clinic, the US non-profit medical practice, education, and medical research group. The company’s Field Asymmetric Ion Mobility Spectrometer (FAIMS) technology is being used in a clinical trial to evaluate its performance as a rapid, point-of-care test to non-invasively assess the adequacy of bowel preparation prior to colonoscopy.
Colonoscopies are one of the most common gastrointestinal endoscopic procedures with approximately 14 million procedures performed annually in the USA. It is estimated that up to a quarter of these procedures have inadequate bowel preparation, resulting in the need for repeat colonoscopies or increasing the risk that diagnosis of disease, such as colorectal cancer, will be missed.
In a pilot study, volatile organic compound (VOC) biomarkers emitted from pre-procedural stool samples were captured and analyzed using Owlstone Medical’s ATLAS Headspace Sampler and Lonestar VOC Analyzer, a FAIMS sensor platform. Results demonstrated that the company’s technology is able to rapidly and effectively identify patients inadequately prepped for colonoscopy with 100% sensitivity and 80% specificity.
Following the successful pilot study, Mayo Clinic and Owlstone Medical have embarked on a larger clinical trial under the guidance of gastroenterologists, Liam Zakko, MD and Kenneth Wang, MD. The trial aims to evaluate FAIMS technology as a pre-endoscopic test to ensure that colonoscopies are only performed when patients are adequately prepped, thus reducing the number of unsuccessful colonoscopy procedures and enabling disease such as colorectal cancer to be diagnosed more effectively.
Billy Boyle, co-founder and CEO at Owlstone Medical, said: “It is a privilege to be working with one of the leading cancer centers in the US and to have achieved such promising results from our initial pilot study together. The work not only validates our technology for use in clinical practice but also demonstrates its scope for wide medical application using other biospecimens in addition to breath.”
The results of the pilot study are to be presented at Digestive Disease Week 2017 in Chicago on 6-9 May 2017.