Shuwen Biotech launches international study of urine test for preeclampsia

Shuwen Biotech has started PRE-CERCA, a multicenter study across Asia to evaluate whether its CercaTest RED urine test can predict preeclampsia in pregnant women with suspected disease. The trial will enroll about 1,300 patients at 13 obstetric centers in seven countries and regions, with results aimed at improving faster risk triage and care decisions.

Why it matters: - Preeclampsia is a leading cause of maternal and neonatal illness and death worldwide. - Faster risk identification could help hospitals decide who needs closer monitoring, admission, or earlier intervention. - A reliable point-of-care test could also reduce unnecessary hospital stays and improve access in outpatient and resource-limited settings.

What happened: - Shuwen Biotech announced the start of PRE-CERCA, short for PREdicting Preeclampsia using CercaTest® RED Urine Test. - The international multicenter clinical study will evaluate whether CercaTest RED™ can accurately predict preeclampsia in women presenting with suspected preeclampsia. - The study is co-led by Professor Liona C. Poon of the Chinese University of Hong Kong and Dr. Long Nguyen-Hoang of Tam Anh General Hospital in Vietnam. - Enrollment is expected to include about 1,300 pregnant women. - The trial will run across 13 obstetric centers in seven countries and regions in Asia.

The details: - Study sites include Prince of Wales Hospital in Hong Kong SAR, China; KK Women's and Children's Hospital and National University Hospital in Singapore; Siriraj Hospital, Maharaj Nakorn Chiang Mai Hospital, Ramathibodi Hospital, and King Chulalongkorn Memorial Hospital in Thailand; Hospital Canselor Tuanku Muhriz and Sarawak General Hospital in Malaysia; Harapan Kita Women and Children Hospital in Indonesia; National Hospital of Obstetrics and Gynecology and University Medical Center Ho Chi Minh City in Vietnam; and Philippine General Hospital in the Philippines. - CercaTest RED™ is a non-invasive urine-based assay. - The test detects disease-associated misfolded proteins implicated in the pathogenesis of preeclampsia. - The product is designed for point-of-care use. - The company says the test could support timely clinical decision-making in hospitals, outpatient clinics, and resource-limited settings. - Professor Liona C. Poon said a rapid and reliable point-of-care test could improve patient management, reduce unnecessary hospital admissions, and enable earlier intervention for women at highest risk.

Between the lines: - The study is being positioned as a practical diagnostic trial rather than a broad laboratory research project. - The Asia-wide site mix suggests Shuwen Biotech is aiming to show the test works across different care settings and populations. - The focus on suspected cases points to triage, not just diagnosis, as the main clinical value. - Shuwen Biotech Executive Chairman Jay Z. Zhang said the PRE-CERCA study is an important milestone in the company's mission to improve maternal health through innovative diagnostics.

What's next: - The trial will now move through patient enrollment and clinical evaluation across participating centers. - Study results will determine whether CercaTest RED™ can be used more broadly as a risk-prediction tool for suspected preeclampsia. - If validated, the test could become part of faster bedside assessment in hospitals and clinics.

The bottom line: - Shuwen Biotech is betting that a urine-based, point-of-care test can help clinicians identify preeclampsia risk earlier and more accurately, with a large Asia-wide study now underway. - More information: the company's announcement