Shuwen Biotech launches South African study of preeclampsia test

Shuwen Biotech has started a prospective clinical study in South Africa to evaluate CercaTest RED, a urine-based point-of-care test, for short-term prediction of preeclampsia in high-risk pregnant women. The trial adds to the company’s Africa and Asia validation program as clinicians look for faster ways to triage patients and reduce unnecessary hospitalization.

Why it matters: - Preeclampsia affects an estimated 2% to 8% of pregnancies worldwide. - The burden is especially high in sub-Saharan Africa, where an estimated 5% to 10% of pregnancies are complicated by preeclampsia. - A fast test that predicts short-term risk could help clinicians triage patients sooner, limit unnecessary admissions and better allocate scarce resources. - The need is most acute in low- and middle-income countries, where access to centralized lab testing is limited.

What happened: - Shuwen Biotech announced the start of a prospective clinical study in South Africa evaluating CercaTest RED for short-term prediction of preeclampsia. - The study will focus on women at high risk who present with suspected preeclampsia. - The study is being led by Professor Jagidesa “Jack” Moodley of the University of KwaZulu-Natal and Dr. Olive Khaliq of the University of the Free State.

The details: - CercaTest RED is a point-of-care urine test for misfolded proteins linked to preeclampsia. - The test uses a simple urine sample and delivers results within minutes. - The device is instrument-free and does not require laboratory equipment or specialized personnel. - Shuwen Biotech says the design makes the test suitable for decentralized facilities and resource-limited settings. - Previous studies at Oxford University, Zhejiang University Women’s Hospital and Shengjing Hospital showed good performance in European and Chinese populations for diagnosing and short-term prediction of preeclampsia. - The South African study will assess performance in African women for screening high-risk patients and identifying women at imminent risk of developing preeclampsia. - The goal is timely intervention while reducing unnecessary hospitalization. - This is the second clinical validation of CercaTest RED in Africa. - The first is the ongoing PROTECT-Africa study in Zimbabwe, Rwanda and Tanzania led by the Africa Clinical Research Network. - Shuwen Biotech also plans the PRE-CERCA multicenter clinical study in Southeast Asia. - Together, the studies are intended to build a multinational evidence base for urinary misfolded protein testing in preeclampsia.

Between the lines: - The South African trial extends validation into another African population with a high maternal health burden. - The multi-continent study program suggests Shuwen Biotech is trying to position CercaTest RED as a broadly deployable triage tool rather than a region-specific product. - The company is also leaning on real-world clinical settings, which could matter for adoption in hospitals and community clinics.

What's next: - The South African study will generate additional clinical data on how well CercaTest RED identifies women at imminent risk of preeclampsia. - Results from South Africa, PROTECT-Africa and PRE-CERCA are expected to strengthen the evidence package supporting the test. - Shuwen Biotech says the broader program could support future use in hospitals, outpatient clinics and community healthcare settings worldwide.

The bottom line: - Shuwen Biotech is broadening clinical validation of CercaTest RED in regions where preeclampsia drives major maternal and perinatal harm, aiming to make faster risk triage more practical at the point of care.