Project Summary The maternal morbidity and mortality associated with gestational hypertension, and specifically pre-eclampsia, remains a serious issue within the United States, affecting up to 8% of pregnancies. In addition, there are also disparities and biases in the healthcare system that leads to a disproportionate incidence of pre-eclampsia for mothers based on racial and socioeconomic factors. The lack of objective and affordable technologies for predicting and diagnosing gestational hypertension and pre-eclampsia plays at least some part in this continued health crisis. The current standard of care for predicting and diagnosing pre-eclampsia relies on biometrics which are prone to bias and lack clinical accuracy. In recent years, new biomarkers, such as Placental Growth Factor (PlGF), have been identified and proven to have strong diagnostic potential for predicting and detecting pre- eclampsia. However, there is not yet an accurate, sensitive, quantitative, and affordable tool for measuring PlGF at the point-of-care (POC). Ricovr Healthcare has invented a novel diagnostic platform for performing an immunoassay using a plasmonic fiber-optic absorbance biosensor (P-FAB). This technology is capable of quantitatively measuring a wide range of biomarkers at ultrasensitive concentrations ranging from 1 fg/mL to 1 ug/mL in as little as ten minutes with a wash-free immunoassay. The platform is low-cost, handheld, and simple to use; it is comprised of a reusable connected reader device and disposable cartridges, enabling POC applications for pre-eclampsia diagnosis such as during routine prenatal visits in primary care or obstetrician/gynecologist offices. This Phase I SBIR proposal aims to demonstrate the feasibility of developing a POC assay for measuring PlGF on the P-FAB platform at clinically relevant concentrations and to validate its performance using authentic biologic samples. The successful completion of these objectives will lead to subsequent analytical and clinical trials to support a 510(k) submission to the FDA as part of a Phase II SBIR proposal. The culmination of these studies will be the development of an objective and affordable POC tool for detecting, predicting, and monitoring pre-eclampsia in clinical settings.