Barriers to overcome for transition of breath tests from research to routine clinical practice

Abstract

Over the last decade noninvasive diagnostic phenotype [13C]- breath tests using suitably labeled 13C substrates as well as breath tests using endogenous/exogenous volatile organic compounds in breath have been extensively researched. Despite the potential benefits of these companion diagnostic tests and stand-alone diagnostic tests for patient/disease stratification and market segmentation to personalize medicine, the clinical and commercial development of these diagnostic tests will need to overcome a number of regulatory, financial and scientific hurdles prior to their acceptance into routine clinical practice. © 2011 IOP Publishing Ltd.