Novel Biomarker Test with Treatment, to Predict and Prevent Miscarriage and Adverse Birth Outcomes in Ethnically Diverse Patient Populations.

The project builds on earlier Innovate funded feasibility work and comprises manufacturing a prototype test for validation and stability testing, for an eventual manufactured form of a novel test for adverse pregnancy outcomes affecting mothers and children. This will include Black and Asian ethnicity patients who are at higher risk of these adverse outcomes The project will include utilising the final format test in a robust Randomised Control Trial, evaluating clinical significance of testing and treating patients to reduce adverse birth outcomes. It will also include an economic analysis to determine the monetary impact of introducing the test into the NHS to establish the economic value in terms of: reduced miscarriage (short-term costs), and longer term costs reduced by reducing adverse birth outcomes and their societal costs The project includes the documentation and documented processes to obtain regulatory clearance for the test in final format.