Preeclampsia (PE) is a serious and potentially fatal disease for pregnant women and their fetus. Nearly 10-15% of all maternal deaths during pregnancy and childbirth are associated with PE (Duley 2009; Lisonkova et al. 2014; Khan et al. 2006), and PE also accounts for 25% of still births and 25% of neonatal deaths (Say et al. 2014). Currently, diagnosis is based on new-onset hypertension and proteinuria or evidence of other maternal organ dysfunction. However, these diagnostic criteria are lacking—cases of PE can exist where the mother does not have clinical signs of disease, but has the same underlying placental pathology (Redman et al. 1977). Identification of these cases is necessary for early clinical intervention.
Scientists at DiabetOmics Inc. have developed a rapid point-of-care screening test that is based on their discovery of a novel biomarker for preeclampsia. I work closely with this company to design clinical trials for each of the 5 “phases” involved with medical assay development, analyze the data and compare performance to the current “gold standard”, and disseminate research findings.
This is a large project with study sites around the world: India, Switerland, Finland, Canada, and more. The work that I do with this company involves statistical analyses on the bleeding edge of science. The current gold standard is faulty and leads to high misclassification of healthy mothers and those with PE. It is my responsibility to use classifcation and prediction methods to accurately idenitfy mothers who are at high risk for developing PE within 4 weeks.