While our ultimate goal is to introduce the engineered bacteria directly into human patients, the next key decision point, and the focus of our PHRT project, involves extensive characterization of the technology in human patient samples cultured in the laboratory. The use of human sample cultures allows us to characterize the technology in a clinical context, which will be a critical element in meeting the extensive regulatory requirements required to deploy the system directly in patients. Towards accomplishing these objectives, we will specifically establish the human sample culture system and characterize our living diagnostic technology in multiple clinical contexts.
Intestinal function is central to the absorption of nutrients in the diet and can be disturbed either by intestinal disease or by malnutrition resulting from a diet that contains insufficient and/or excess nutrients. Over 800 million people globally suffer from calorie or micronutrient insecurity, which particularly affects growth, development, and immunity. Approaches to assess the composition of the intestine are thus central to ensure health and diagnose disease. Clinical methods for assessing nutrition are however mainly indirect and/or require fasting or purging. Therefore, the challenge remains to have a non-invasive system to faithfully sense nutrients in fed and fasted individuals at the actual sites of nutrient uptake in the intestine.
