Shuwen Biotech launches dual rapid test to help prevent congenital syphilis

Shuwen Biotech introduced SyphiDuo™, a point-of-care test designed to speed syphilis screening in pregnancy and support same-day treatment decisions, with distribution now open across Africa, Asia and Latin America. The launch comes as WHO-backed dual testing gains momentum to reduce stillbirths, neonatal deaths and other preventable outcomes tied to congenital syphilis.

Why it matters: - Congenital syphilis remains a major preventable cause of stillbirth, neonatal death, prematurity and infection. - Faster screening in pregnancy can reduce missed treatment opportunities and improve same-day care in low-resource settings. - A dual rapid test can help clinics move from multi-visit workflows to immediate test-and-treat decisions.

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

The details: - The test uses fingerstick whole blood, venous whole blood or serum. - SyphiDuo™ does not require laboratory instrumentation or specialized personnel. - The product is designed to support decentralized healthcare settings and primary care clinics. - The company says the test can reduce overall testing costs, lower loss to follow-up and simplify antenatal screening workflows. - WHO estimated 8 million adults acquired syphilis in 2022. - WHO 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. - WHO published a guideline in July 2024 that strongly recommends dual treponemal/non-treponemal rapid diagnostic tests for syphilis testing. - WHO also published a target product profile for these tests in 2021. - Clinical studies found SyphiDuo™ had 99.4% sensitivity and 97.4% specificity for treponemal antibodies. - The same studies found 100.0% sensitivity and 97.0% specificity for non-treponemal antibodies at a titer of 1:8 or higher. - Shuwen Biotech says SyphiDuo™ is one of the first dual-marker syphilis rapid tests to exceed WHO target product profile requirements. - Jay Z. Zhang, Shuwen Biotech executive chairman, said the test could simplify screening workflows, improve same-day treatment rates and strengthen efforts to eliminate congenital syphilis.

Between the lines: - The launch positions Shuwen Biotech inside a global push for better antenatal syphilis screening in settings where lab access is limited. - The product’s value proposition is not just speed. It is also fewer follow-up visits, simpler clinical decisions and lower operating costs. - The WHO recommendation gives the category stronger policy support, which could help adoption by ministries of health and maternal health programs.

What's next: - Shuwen Biotech is seeking distribution and commercialization partners in Africa, Southeast Asia, South Asia, Latin America and developed markets. - The company plans to work with ministries of health, international organizations, maternal health programs, NGOs and commercial partners to expand access. - Wider uptake will depend on procurement, regulatory pathways and local implementation in antenatal care systems.

The bottom line: - Shuwen Biotech is betting that a cheaper, faster dual syphilis test can help close a dangerous screening gap in pregnancy and move health systems closer to eliminating congenital syphilis.