SBIR Phase II: Absolute protein quantitation in in vitro diagnostics for gut inflammation

The broader impact of this Small Business Innovation Research (SBIR) Phase II project is to advance clinical methods that address the extensive physiological variation that is age- and race-dependent. Well-publicized over the last few decades is the lack of healthcare solutions for diseases in preemie babies, who are born to mothers with significant socioeconomic inequalities. Case in point, necrotizing enterocolitis (NEC) is a common and often fatal gastrointestinal, or gut, emergency in premature infants that disproportionately affects African American babies. The disease has not only confounded doctors and nurses for 200 years, but also these neonatal emergencies are also frightening to almost all preemie care providers due to its high mortality rate. Its healthcare in the US requires $3 billion annually due to repeated x-ray testing, surgery, longer hospital stays, and long-term complications of its survivors. An early and accurate diagnostic test for NEC would be a disruptive paradigm shift in preemie intensive care: it would enable medical intervention to be more effective, reduce risk of disease progression, decrease medical care expenses by hundreds of millions annually, and lower mortality. The proposed project will develop requisite reagents for a diagnostic test that will enable detection of infant proteins that play a role in gut health. Absolute quantitation is a prerequisite for data interpretation and validation between experiments, laboratories, and testing platforms. Research objectives are directed toward critical technical hurdles: (1) determination of optimal reference standard to quantitate host biomolecules in clinical settings and (2) understanding the usage limitations of these reference standards in the background of high variation in the human population. Native and recombinant candidates will be compared and analyzed with various methods. Anticipated results are reference standards that are age-specific for diagnostic use in the most fragile and smallest patients and that are acceptable to regulatory stakeholders. 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.