Shuwen Biotech Announces PRE-CERCA International Study Evaluating CercaTest RED™ for Prediction of Preeclampsia

DEQING, CHINA, August 17, 2026 /EINPresswire.com/ -- Shuwen Biotech today announced the initiation of the PRE-CERCA study (PREdicting Preeclampsia using CercaTest^® RED Urine Test), an international multicenter clinical study evaluating whether CercaTest RED™, a next-generation point-of-care urine test, can accurately predict preeclampsia in women presenting with suspected preeclampsia.

The study is co-led by Professor Liona C. Poon, an internationally recognized expert in maternal-fetal medicine and preeclampsia from the Chinese University of Hong Kong, and Dr. Long Nguyen-Hoang from Tam Anh General Hospital (Vietnam). The study will enroll approximately 1,300 pregnant women in 13 leading obstetric centers in 7 different countries and regions in Asia including:
• Prince of Wales Hospital, Hong Kong SAR, China
• KK Women's and Children's Hospital, Singapore
• National University Hospital, Singapore
• Siriraj Hospital, Mahidol University, Thailand
• Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Thailand
• Ramathibodi Hospital, Mahidol University, Thailand
• King Chulalongkorn Memorial Hospital, Thailand
• Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia, Malaysia
• Sarawak General Hospital, Malaysia
• Harapan Kita Women and Children Hospital, Indonesia
• National Hospital of Obstetrics and Gynecology, Vietnam
• University Medical Center Ho Chi Minh City, Vietnam
• Philippine General Hospital, University of the Philippines Manila, Philippines

Preeclampsia remains a leading cause of maternal and neonatal morbidity and mortality worldwide. Women presenting with symptoms suggestive of preeclampsia often require intensive monitoring and hospitalization due to the lack of rapid and accessible tools to identify those at highest risk of developing the disease.

CercaTest RED™ is a non-invasive urine-based assay that detects disease-associated misfolded proteins implicated in the pathogenesis of preeclampsia. Designed for non-invasive point-of-care use, the test has the potential to support timely clinical decision-making in hospitals, outpatient clinics, and resource-limited settings.

“Women with suspected preeclampsia present a significant clinical challenge,” said Professor Liona C. Poon, Principal Investigator of the PRE-CERCA study. “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.”

"The PRE-CERCA Study marks an important milestone in our mission to improve maternal health through innovative diagnostics," said Jay Z. Zhang, Executive Chairman of Shuwen Biotech. "We are honored to collaborate with Professor Liona Poon and our clinical partners across Asia to evaluate a new approach for the identification of women at risk of preeclampsia."

About Shuwen Biotech
Shuwen Biotech is an integrated biotech company with offices in China and Germany. Founded on the principles of innovation, patent protection, and international collaboration, Shuwen established strategic partnerships with leading academic and commercial institutions to commercialize first-in-class diagnostic technologies and patents, and has developed a range of novel diagnostics in the fields of cancer and women’s health. Shuwen has also developed quality companion diagnostics and provides central lab biomarker testing services to leading pharmaceutical developers and hospitals. Shuwen houses an in-house development team, CAP-accredited central labs, and GMP/ISO13485-certified IVD manufacturing facilities, all in line with global standards to continue to deliver transformational products and services to its customers globally and open new possibilities in the advancement of health.

Jay Zhe Zhang
Shuwen Biotech Co. Ltd.
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