Pilot study demonstrates FAIMS technology is able to detect patients inadequately prepped prior to colonoscopy with 100% sensitivity
Cambridge, UK, April 19, 2017: Owlstone Medical, a diagnostics company developing a breathalyzer for disease, today announced it has entered into collaboration with Mayo Clinic, the leading US non-profit medical practice, education, and medical research group. The company’s 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 Field Asymmetric Ion Mobility Spectrometer (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, M.D. and Kenneth Wang, M.D. 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. The results of the pilot study are to be presented at Digestive Disease Week 2017 in Chicago on 6-9 May 2017.
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.”
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Photo: Owlstone Medical’s Lonestar VOC Analyzer
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Owlstone Medical has developed a breathalyzer for disease. With a focus on non-invasive diagnostics for cancer, inflammatory disease and infectious disease, the company aims to save 100,000 lives and $1.5B in health care costs by 2020.
The company’s microchip FAIMS (Field Asymmetric Ion Mobility Spectrometer) sensor is a platform technology that can be programmed in software to detect targeted biomarkers of disease in breath (and other bodily fluids). FAIMS can be used in clinical diagnostics and precision medicine with application in cancer and a wide range of other medical conditions. Highly sensitive and selective, these tests allow for early diagnosis when treatments are more effective and where more lives can be saved.
Owlstone Medical is currently developing tests for lung and colorectal cancer, two of the most common cancer killers worldwide, and for asthma stratification by therapeutic response. The company also sells R&D tools and services to academic, clinical and pharma partners who want to develop breath based diagnostics for their own applications.
Founded in 2004 as a spin-out from the Engineering Department at the University of Cambridge, Owlstone Inc is a profitable business selling its proven FAIMS technology to military and industrial customers globally. Owlstone Medical was spun out from Owlstone Inc in 2016 to develop and commercialise FAIMS in diagnostic applications.
Owlstone Medical is headquartered in Cambridge, UK, with offices in London, UK.
About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org/ .