SBIR Phase I: Development of a High-Throughput Fecal Exfoliome Analyzing Platform for Clinical Drug Development

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project lies in enabling pharmaceutical companies to better evaluate and tailor treatments for inflammatory bowel disease (IBD), a chronic condition that affects over 3 million people in the United States. Drug development for IBD is hindered by the lack of scalable, non-invasive tools for monitoring disease activity and understanding patient variation. This project addresses that gap by developing a stool-based platform capable of capturing real-time molecular information about gut health. Unlike invasive procedures like endoscopy or conventional stool tests that offer only limited insight, this method provides a more detailed, data-rich view of gastrointestinal function over time. By helping pharmaceutical companies evaluate new drugs, identify patients most likely to benefit, and improve the design of clinical trials, this technology holds the potential to boost success rates and lower development costs. The platform is designed for integration into pharmaceutical pipelines through sustainable business models with near-term revenue and long-term licensing opportunities. On top of its commercial potential, this technology aims to advance public health by enabling more personalized treatment strategies and better outcomes for people living with IBD. This Small Business Innovation Research (SBIR) Phase I project addresses a long-standing challenge in healthcare for gut disorders: how to non-invasively access meaningful information about the human gut. Stool contains human genetic material shed from the lining of the intestine, but analyzing this material has been difficult due to the overwhelming presence of microbes and food debris. This project builds on a method that captures human gene activity from stool and aims to expand its use in drug development. The project will enhance the method to measure the activity of over 2,000 genes related to gut health and immune function, develop software tools to interpret the data, and apply the approach to biobanked stool samples from patients with inflammatory bowel disease (IBD). By connecting gene activity patterns in stool with how patients responded to specific drug treatments, this research may help identify genetic signals that predict whether a treatment will work. The anticipated results will demonstrate how stool samples could guide more personalized and effective treatment design for people with gut disorders and support the development of new therapies. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.