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

该项目建立在之前Innovate资助的可行性工作的基础上，包括制造用于验证和稳定性测试的原型测试，以及最终制造的影响母亲和儿童的不良妊娠结局的新型测试形式。这将包括黑人和亚裔患者，他们具有较高的不良结局风险。该项目将包括在一项稳健的随机对照试验中使用最终格式测试，评估检测和治疗患者以减少不良生育结果的临床意义。它还将包括一项经济分析，以确定在NHS中引入该测试的经济影响，以确定在以下方面的经济价值：减少流产(短期成本)，以及通过减少不良生育后果及其社会成本来降低长期成本。该项目包括文件和记录的程序，以获得最终格式的测试的监管许可。

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.