Notice of Intent to Sole Source - FDA Microbiome

The intended contractor houses a research and development group that has honed years of experience in a highly specific and technical area. To accomplish the tasks as written in the SOW, a strong inter-disciplinary group is required for analysis of experimental and clinical data along with a unique combination of expertise in microbiology, bioinformatics, and ecological modeling. In addition, the principal lead scientist has 10+ years of experience running such experimental and theoretical systems. Thus, these knowledge, skills, and abilities will be used to create a product which does not exist and has no comparable platform available in the open market. This work will build on the current prototype system that tracks multiple metabolite biomarkers of disruption in a static vial reactor system (SVRS) culture. The objective of this project is to validate these biomarkers by monitoring them in human subjects with and without antibiotic-mediated disruption. This work will yield a SVRS protocol that is demonstrably relevant to in vivo intestinal microbiome function in humans.