Challenges in clinical breath research development

Novel diagnostics have much promise, but they can be difficult to develop from concept to clinical utility. Herein, we review concepts germane to breath research, including metabolite selection and development vision, and offer some practical guidance. Although breath sampling is safe and can inexpensively and quickly deliver measurement results, clinical research evaluating breath analysis must adhere to the same safety and efficacy standards as other forms of clinical trials. A cohesive and well-resourced multidisciplinary team is required. Convincing results are expensive and time consuming to obtain, but essential for clinical, and ultimately, commercial success.