Shuwen Biotech launches dual rapid syphilis test for pregnancy screening

Shuwen Biotech launched SyphiDuo™, a dual point-of-care test designed to speed syphilis screening and treatment in pregnancy, with distribution plans across Africa, Asia, Latin America and other low- and middle-income markets. The company says the test can help reduce missed diagnoses and support global efforts to eliminate congenital syphilis.

Why it matters: - Congenital syphilis remains a major preventable cause of stillbirth, neonatal death, prematurity and infection in newborns. - Shuwen Biotech is targeting settings where pregnant women face high syphilis burden and limited access to laboratory testing. - The company says SyphiDuo™ could support same-day treatment and reduce missed follow-up visits in antenatal care.

What happened: - Shuwen Biotech announced a global initiative on July 27, 2026, to introduce SyphiDuo™, a dual point-of-care rapid diagnostic test for syphilis. - The test simultaneously detects treponemal and non-treponemal antibodies on a single device. - SyphiDuo™ is being made available for partnering and distribution in Africa, Asia, Latin America and other low- and middle-income countries. - The announcement was made in Berlin, Germany.

The details: - SyphiDuo™ is designed for a “Test and Treat” approach that lets providers make treatment decisions during the patient’s first visit. - The test uses fingerstick whole blood, venous whole blood or serum. - No laboratory instrumentation or specialized personnel are needed to run the test. - Shuwen Biotech says the design can simplify antenatal screening workflows, lower testing costs and improve access in primary care and other resource-limited settings. - The World Health Organization estimated that 8 million adults acquired syphilis in 2022. - The World Health Organization estimates syphilis in pregnancy causes about 700,000 congenital syphilis cases and 390,000 adverse pregnancy outcomes each year. - In many low- and middle-income countries, 1% to 5% of pregnant women attending antenatal clinics are infected with syphilis. - The World Health Organization issued a strong recommendation in July 2024 for dual treponemal and non-treponemal rapid diagnostic tests in syphilis testing. - The World Health Organization published a Target Product Profile for such tests in 2021. - Multiple clinical studies found SyphiDuo™ had 99.4% sensitivity and 97.4% specificity for treponemal detection. - Those studies also found 100.0% sensitivity and 97.0% specificity for non-treponemal detection at a titer of 1:8 or higher. - Shuwen Biotech says SyphiDuo™ is one of the first dual-marker syphilis rapid diagnostic tests to exceed the World Health Organization’s preferred performance requirements. - Jay Z. Zhang, executive chairman of Shuwen Biotech, said the test could simplify screening workflows, improve same-day treatment rates and help make high-quality syphilis screening accessible to more women worldwide. - The company is seeking distribution and commercialization partners in Africa, Southeast Asia, South Asia, Latin America and other emerging markets, as well as developed markets. - Shuwen Biotech says it wants to work with ministries of health, international organizations, maternal health programs, NGOs and commercial partners to expand access.

Between the lines: - The launch fits a broader push toward decentralized diagnostics that can deliver results without lab infrastructure. - The company is positioning SyphiDuo™ as both a public-health tool and a commercial product for markets with limited access to conventional serology. - The WHO recommendation and target product profile give the dual-test category added policy relevance.

What's next: - Shuwen Biotech will look for distribution and commercialization partners across target regions. - The company will likely focus on adoption in antenatal screening programs and other primary-care settings. - Broader use will depend on procurement decisions by health systems, NGOs and other public-health buyers.

The bottom line: - Shuwen Biotech is betting that a single rapid dual-marker test can make syphilis screening faster, cheaper and more actionable where it matters most: pregnancy care in resource-limited settings.