Clinical OMICS

MAR-APR 2017

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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12 Clinical OMICs March/April 2017 www.clinicalomics.com In the Clinic T wo years after his wife, the mother of his twin sons, died of colorectal cancer at age 36, Billy Boyle is leading a Cambridge, U . K . -based diagnostics developer in launching a 1,400-patient clinical trial to assess the accuracy of its diagnostic technology in detect- ing the disease early, from samples of breath and urine . Boyle is co-founder and CEO of Owlstone Medical, which has com- menced the 1,400-patient InTERCEPT trial . The study will examine the com- pany's microchip Field-Asymmetric Ion Mobility Spectrometer (FAIMS) platform technology, a noninvasive chemical detection system designed to assess a patient's metabolome by measuring volatile organic compound (VOC) biomarkers from breath, urine, and other bodily fluids. VOCs are the end product of met- abolic processes within a person's cells and tissues, within their micro- biome, and from their response to environmental exposures. Since VOC production is linked directly to met- abolic activity, the compounds can be sampled quickly and noninvasively from breath, urine, or other bodily flu- ids. Changes in VOC concentrations take place at the very earliest stages of disease, so detection of the compounds can allow disease diagnosis before other physical symp- toms become apparent . "Over time, it's a bit like getting a window into a much larger vol- ume of blood," Boyle told Clinical OMICs . "Once every minute, your entire recir- culated blood flow goes around your body . By sampling the chemicals com- ing from breath over that time period, you have really quite unbelievable test sensitivity in terms of trying to detect disease . "Breath gives you that real unique advantage in terms of the test sensi- tivity, but also from the patient per- spective . It's the patient's compliance and acceptability which is really important, and has historically been a major issue in colorectal cancer where other tests, be it a fecal-based test, or a colonoscopy, are very unpleasant," Boyle added . In the InTERCEPT trial, patients will have both their urine and breath tested, using Owlstone Medical's ReCIVA breath sampler and Lonestar gas analyzer . "We will work out which will give us the most optimal separation, and max- imize the sensitivity and specificity. Or perhaps even a combination might improve it . We don't know, and that has never been done before, which is why we wanted to test it in a large series," said Ramesh P . Arasaradnam, Ph . D . , principal investigator for InTERCEPT . Dr . Arasaradnam is an associate professor of gastroenterology at the University of Warwick and a consul- tant gastroenterologist at University Hospital Coventry and Warwickshire NHS Trust . Both institutions are part- nering with Owlstone in the trial, which is expected to take 12 to 18 months to complete . InTERCEPT follows up on a 2014 pilot study assessing FAIMS in col- orectal cancer detection . In the study, published in PLoS One, the technol- ogy showed a sensitivity of 88% in detecting VOC biomarkers for colorec- tal cancer in urine, and 62% sensitiv- ity in detecting advanced adenomas in urine. Detection of VOCs in breath via FAIMS has also been pilot stud- ied in conditions that include hepatic encephalopathy, inflammatory bowel disease and tuberculosis . "The wide application in essence Validating VOCs Owlstone Medical Tests Breath, Urine for Cancer Biomarkers in Clinical Trial Alex Philippidis, Senior News Editor "By sampling the chemicals coming from breath... you have really quite unbelievable test sensitivity in terms of trying to detect disease." —Billy Boyle, co-founder & CEO, Owlstone Medical

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