Every year, 10 million women worldwide develop pre-eclampsia, with 76,000 pregnant women dying from the condition and related hypertensive disorders, and more than 500,000 babies dying as a result of pre-eclampsia.
Morgan IAT is developing a screening tool to identify pregnant women at risk of pre-eclampsia, involving the analysis of salivary uric acid. Salurate is a novel screening test that identifies women who will go on to develop pre-eclampsia later in pregnancy. The test is based on the weekly self-monitoring of the level of uric acid in the mother’s saliva, (‘Salurate’), from week 20 to conclusion of pregnancy.
A link between pre-eclampsia and the level of uric acid in maternal saliva has been shown in two studies led by Morgan IAT. In a pilot study of 135 maternities, reported by the University of Southampton, Salurate clearly indicated potential to enhance predictive capability for pre-eclampsia and related maternal and foetal adverse outcomes, relative to traditional indicators. A follow up study of over 1,000 women produced further evidence of the potential of Salurate to provide earlier prediction of pre-eclampsia. However, the methodology of sending the samples via post was not sufficiently acceptable to busy, pregnant women and as a consequence samples were delayed and the uric acid in the sample degraded.
Accordingly, a single-use, disposable device was developed by MIAT to enable users to collect and test their own saliva samples. This unique design combines the Salurate biomarker for pre-eclampsia, with a simplified sampling device and colorimetric test-strip detection. The Salurate device will measure the trends of the uric acid in maternal saliva to give a prediction of the risk of potential adverse outcomes before 32 weeks, which is much earlier than the current combined markers of hypertension and proteinuria which can be as late as 37/38 weeks. A further significant development was to incorporate colour measurement by smartphone which then allowed for transmission of results to a Cloud-based processing centre for analysis, a true Telehealth device giving clinicians instant access to results.
The device, which is cheap, simple and non-invasive, is currently being trialled by 400 women in Denmark. The intention is to confirm that Salurate monitoring can enhance the accuracy of risk assessment of disposition to pre-eclampsia, allowing for more reliable and cost-effective triage to low and high-risk management plans, saving lives of both mothers and babies.