I-Corps: Translation Potential of a Point-of-Care Diagnostic for Preeclampsia

This I-Corps project is based on the development of a diagnostic test for preeclampsia, a pregnancy complication associated with high blood pressure. Preeclampsia is one of the leading causes of maternal morbidity and is estimated to occur in up to 10% of all pregnancies. When left untreated, preeclampsia can result in serious and sometimes fatal complications including stroke, seizure, kidney disease, heart disease, and preterm birth. Diagnosis of preeclampsia remains a significant challenge. The current diagnostic standard for preeclampsia relies on insensitive tests and outdated standards, allowing diagnosis only after evidence of organ damage in the mother. Also, preeclampsia tests generally need to be performed in clinical labs by trained personnel, leading to increased costs, decreased accessibility, and decreased likelihood of catching preeclampsia before it becomes dangerous to mother and fetus. This technology addresses these challenges by providing a preeclampsia diagnostic that can be used at home by untrained personnel with just a finger-stick volume of blood that is no more difficult to interpret than an at-home COVID test. This technology may improve detection, treatment, and management of preeclampsia and improve the outcomes of pregnant individuals with this condition.

This I-Corps project utilizes experiential learning coupled with a first-hand investigation of the industry ecosystem to assess the translation potential of a preeclampsia diagnostic that can be used at home by untrained personnel with just a finger-stick volume of blood. The technology is based on a recently developed cell-free synthetic biology technique to measure proteins harnessed from nature and re-engineered to detect recently discovered biomarkers for preeclampsia in a mother’s blood sample. A visually interpretable color change that provides semi-quantitative screening for preeclampsia has been created that is similar to an at-home COVID test. The use of cell-free systems, which consist of purified bacterial extracts, enables easy reprogramming to create diagnostics for new diseases without the extensive, expensive, trial-and-error development cycle associated with existing point-of-care protein measurement techniques. This system is compatible with the lyophilization that is needed to enable shelf-stable products that can be distributed commercially. This technology may allow the development of at-home screening and diagnostic testing for preeclampsia and for many other different types of diseases in the future with the goal of improving patient outcomes.

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.

Award Number: 2521137
Principal Investigator: Mark Styczynski
Funds Obligated: $50,000
State: GA