A Rapid Non-Invasive Device for Monitoring Preeclampsia in High Risk Pregnancy

Accel Diagnostics, Llc, Houston TX

Investigators

Abstract

Project Summary Preeclampsia (PE) is a pregnancy-specific life-threatening disorder and one of the leading causes of maternal and fetal morbidity and mortality. It is responsible for approximately 16% of maternal deaths in the US and is the leading cause of intensive care unit admissions in the 6 weeks following delivery. Rates of severe PE have tripled since 1980. The diagnosis of PE is complicated by heterogeneity in the clinical presentation and symptom overlap with other medical conditions seen during pregnancy. Maternal and perinatal outcomes for women with PE can be significantly improved if the condition is identified early and intervention and treatment strategies can be accessed quickly. The current gold standard in clinical practice is to screen women at risk for PE based on clinical history and risk factors. While this strategy is well accepted, it remains a broadband screening with limited specificity and a high rate (64%) of false positives. Recent studies have shown that measurement of PlGF and sFlt-1 in the blood permit tracking the disease onset in patients at high-risk for developing PE. There is an urgent need for the development of an innovative device for a rapid, portable, and cost-effective testing of PE that leverages these biomarkers and can be used in a wide variety of health care environments, namely centralized laboratories, physician's offices, and at home. The objective of this Phase I proposal is to develop a novel reader-free point-of-care (PoC) device, PreeMo, for the monitoring and management of PE. PreeMo is an elegantly simple, inexpensive, rapid, accurate and easy to use device to measure quantitatively both PlGF and sFlt-1 in a single test, in less than two minutes, from finger prick blood sample. Importantly, the PreeMo device will feature all of the characteristics required for successful use in low resource settings with an ultimate goal of becoming FDA cleared for home use. The development plan will follow a Phase I for the identification and optimization of affinity reagents, and a Phase II to pre-clinically validate the PreeMo assay with clinical samples from women with a confirmed diagnosis of PE. Specifically, this Phase I efforts will focus on comprehensive development of the multiplex assay format and extended pre-clinical validation. Aim 1. PreeMo Development and Optimization: We will develop a multiplex assay prototype capable of performing bioassays for sFlt-1 and PlGF in parallel from a single blood sample. Aim 2. PreeMo Pre-clinical validation vs. benchmark lab-based device: PreeMo prototype test cards will be challenged with serum collected from pregnant women with confirmed PE along with sample specific de-identified medical history. Benchmarking will be performed against laboratory values. The successful development of this technology could significantly reduce hospitalization times and help prevent maternal and fetal morbidity arising from PE.