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

This is the authors' abstract. We don't add key points for this paper.

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.