Pre-eclampsia Diagnostic - Isis Project No 7305

A biomarker for assessing the risk of developing pre-eclampsia during pregnancy.

A novel biomarker

Pre-eclampsia (PE) is a disease affecting up to 3% of pregnancies that can be life threatening to both mother and baby. It is a leading cause of maternal mortality in the developing world and even in the developed world it remains a cause of maternal death. Now, Oxford researchers have identified a novel biomarker, sST2, that is significantly raised in the circulating blood of pregnant women suffering from pre-eclampsia and, most importantly, it is detectable before the onset of clinical symptoms.

The sST2 biomarker

• Can be identified from testing blood samples
• Immunoassay-based
• Detection possible via an antibody that binds to sST2

The work undertaken by the Oxford researchers on detection of sST2 has demonstrated a high level of robustness and reproducibility, which they believe is an essential foundation for the development of a future clinical diagnostic tool.

Supporting data

Studies compared blood samples from women with and without PE (n=50 per group). The Oxford biomarker, sST2, was significantly higher in the PE group than in the normal pregnant group (p=<0.001). The largest differences observed were in early onset PE (21-28 weeks).

sST2 was measured in blood samples from both groups throughout each trimester of pregnancy, with an additional sample taken at the time of diagnosis (n=15). There was a significant increase in sST2 in the third trimester of both groups compared to the first and second trimesters (p<0.01). sST2 levels were significantly higher in the third trimester of pre-eclamptic pregnancies compared to third trimester samples from ‘normal’ pregnancies (p<0.001) even before the onset of clinical symptoms. Although larger studies are still required to identify precisely how far in advance of disease onset sST2 is elevated, it is possible that alone – or in conjunction with other proteins – the biomarker may effectively stratify pregnant women into high or low risk for pre-eclampsia, allowing antenatal care to be tailored accordingly.

Ongoing research and patent status

Further work is ongoing at the University to investigate sST2, including a systematic screen to determine exactly how early in pregnancy sST2 changes that are predictive for pre-eclampsia can be seen. A PCT patent application has been filed and Isis would like to hear from companies interested in this technology. Please click on the link below to contact the Technology Transfer Manager.

Reference

Granne et al. (2011) ST2 and IL-33 in Pregnancy and Pre-Eclampsia. PLoS ONE 6(9): e24463. doi:10.1371/journal.pone.0024463

PCT Application: WO2012017203

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