PFI-TT: Non-invasive Multiplex Blood Test for Early Detection of Preeclampsia

University Of Washington, Seattle WA

Investigators

Abstract

The broader impact of this Partnerships for Innovation - Technology Translation (PFI-TT) project includes three key aspects: (1) Societal Benefits: By enhancing the early and accurate prediction of preeclampsia - a pregnancy complication characterized by high blood pressure and signs of damage to other organs - this project aims to significantly reduce its prevalence and severity; (2) Commercial Potential: By filling a critical gap in prenatal care with its capability for early preeclampsia detection, this test is poised for commercial success; and (3) Educational Impact: The project will provide comprehensive research and commercialization training to Bioengineering predoctoral and postdoctoral researchers. Given the critical need and currently limited options, the test is well-positioned to become a routine screening tool for high-risk pregnancies, and potentially, for all pregnancies during the first prenatal visit. Improved predictive capabilities are expected to enhance maternal health outcomes, with the potential to save tens of thousands of lives annually. This solution could capture a significant market share of the expanding field of prenatal screening. The team will serve as technical mentors for the institutional Biomedical Regulatory Affairs Graduate Program and community-based Science, Technology, Engineering and Mathematics (STEM) enrichment programs focused on students in K-14 education. The project aims to advance the detection of vascular dysfunction, particularly preeclampsia, by optimizing a blood test that targets disease-inducing signaling proteins on the surface of vascular cells. A major hurdle in utilizing signaling proteins as diagnostic biomarkers is the typical requirement for invasive tissue biopsies, a procedure that is particularly impractical for screening preeclampsia during pregnancy. The project will use circulating vascular cells as proxies to profile the vascular biomarkers. Building on the established single-plexing antibody-based method, which can successfully distinguish vascular biomarker distributions in premenopausal versus postmenopausal females, the team seeks to advance this approach for broader clinical use. The current single-plexing antibody-based method lacks efficiency and cost-effectiveness for clinical translation. To address these limitations, multiplexing, shelf-stable, cost-effective probes that enhance commercialization potential will be developed. The research will unfold in two phases: first, developing multiplexing probes capable of precisely quantifying two or more cell-surface protein biomarkers, creating an effective, economical, and non-invasive tool. Second, validating the accuracy and specificity of the test in a clinical setting, beginning with patients already diagnosed with preeclampsia. This validation is essential for progressing toward a prospective study aimed at early-stage prediction of preeclampsia, crucial for timely and effective interventions. 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.