Cerca Biotech has announced the start of Shuwen Biotech’s ‘PreShield Study’ in China to assess ‘CercaTest RED’, a urine-based pre-eclampsia self-testing device for pregnant women.
The study aims to assess the device when used for screening of pre-eclampsia. Around 2%-10% of pregnancies worldwide are affected by this condition.
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Intended for women with a gestational age of 20 weeks or more, the device received the European CE mark for professional use. It was recently granted approval in China for professional and at-home self-testing.
The one-step process of the test eliminates the need for additional laboratory equipment and claims to offer easy-to-read visual outcomes within ten minutes.
Shuwen’s CercaTest RED is a non-invasive device designed for the diagnosis and prediction of short-term pre-eclampsia. The technology is based on the identification of misfolded proteins in urine.
The original discovery of the correlation between misfolded proteins in urine and pre-eclampsia was made by Yale University professor Irina Buhimschi.
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By GlobalDataShuwen holds an exclusive patent licence for this technology in specific regions, including China.
Sponsored by Shuwen and led by the China Healthy Birth Science Association, the multicentre prospective study involves 12 hospitals in Northwest China.
It will enrol 1,500 pregnant women identified to be at high pre-eclampsia risk. They will perform serial self-testing with the device throughout their pregnancy. The study is anticipated to be concluded by the year-end.
Shuwen Biotech medical director Ada Yuan said: “In previous studies, CercaTest RED has shown promising clinical value in pre-eclampsia screening, triage and aid-in-diagnosis in second and third trimesters.
“PreShield is one of the largest studies for self-testing in pre-eclampsia, and we hope to further validate, through this study, the value of the device in at-home or resource-limited settings. We believe close monitoring at the home of women with high-risk factors, or suspected, of pre-eclampsia improves health and saves lives.”
