Cerca Biotech and Shuwen Biotech announce that Shuwen has embarked on a multicentre prospective study in China evaluating CercaTest RED for self-testing by pregnant women for pre-eclampsia screening (the “PreShield Study”).
CercaTest RED is a proprietary point-of-care device to aid in the diagnosis and short term prediction of pre-eclampsia based on the presence of misfolded proteins in the urine of pregnant women. The association of misfolded proteins in urine with pre-eclampsia was originally discovered by Professor Irina Buhimschi at Yale University, and Shuwen has exclusive patent license to the technology in certain territories including China.
The CercaTest RED device developed by Shuwen has previously been CE marked in Europe for professional use and recently approved in China for both professional use and self-testing at home. The device employs a one-step process using urine samples and requires no extra lab equipment. The test generates an easy to read visual test result in less than 10 minutes. The device has previously demonstrated good performance in several clinical studies at leading hospitals in China and the UK.
The PreShield Study is a large multicentre study organized and led by “China Healthy Birth Science Association” and sponsored by Shuwen. Twelve leading hospitals in Northwest China will participate in the study enrolling a total of 1500 pregnant women who are between 18 and 20 weeks of gestation age and are identified to be at high risk for pre-eclampsia. The enrolled women will conduct serial self-testing with CercaTest RED during their pregnancy. Shuwen expects the study to be completed by the end of 2025.
Commenting on the PreShield Study Ada Yuan, MD, Shuwen’s Medical Director stated, “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 home of women with high risk factors, or suspected, of pre-eclampsia improves health and saves lives.”
