Salurate - Validation of salivary uric monitoring for early prediction of hypertensive disorders in pregnancy

Over 10% of pregnant women experience high blood pressure (hypertension) and related conditions such as pre-eclampsia (PE). Untreated PE is the second biggest cause of maternal deaths - 63,000 annually worldwide, but despite this, there is no way of accurately predicting who may develop PE. This causes anxiety for expectant mothers and puts them and their baby at risk. The NHS incurs avoidable costs from monitoring pregnant women who are wrongly assigned as having a high-risk pregnancy, emergency interventions on women with undiagnosed PE and paying compensation when mothers or babies suffer due to undiagnosed hypertensive disorders.

This project builds upon research that has shown that measuring the concentration of a chemical called uric acid in saliva (SUA) can predict which expectant mother will develop hypertension. Over the last ten years, Morgan Innovation and Technology (MIAT) have used a mixture of grant funding and own revenues to:

\*Develop chemistry so that SUA causes a measurable colour change on a test paper, proportional to its concentration

\*Develop a saliva sampling device that is easier to use than a typical pregnancy test

\*Develop technology to relate colour change to SUA concentration

\*Relate SUA concentration to how likely it is that a pregnant woman will develop hypertensive disorders

We call this novel technology Salurate.

Currently patients defined as high risk from hypertension attend extra clinics for regular blood pressure and urinary protein measurement. Yet this monitoring is not effective at identifying women who may be at imminent risk of developing complications such as PE. Salurate can identify these women more accurately, with a non-invasive test that women can use at home. By identifying women more accurately, and earlier, women who really need it can get the targeted treatment they require.

Our aims in this project are:

1.Maximise performance and minimise environmental impact of sampling device

2.Conclude associated software development

3.Carry out a clinical study on 4,000 participants to validate the data-learning algorithm from a representative UK population

4.Produce a technical file compilation for regulatory approval (UKCA marking)

We plan a pilot launch for Salurate within six months of finishing the project. Ultimately, we aim to save the NHS £22m per year and improve patient outcomes by reducing inconvenient clinic attendances and identifying the women who need further interventions more accurately.