Shuwen Biotech Launches SyphiDuo™, a Novel Dual Rapid Test to Support Global Efforts to Eliminate Congenital Syphilis

Affordable POCT with Superior Performance Enables Precision Interventions of Syphilis in Pregnancy

BERLIN, GERMANY, July 27, 2026 /EINPresswire.com/ -- Shuwen Biotech today announced a global initiative to introduce its innovative dual point-of-care test (POCT), SyphiDuo™, to support global efforts to eliminate congenital syphilis. SyphiDuo™ is a rapid diagnostic test (RDT) that simultaneously detects treponemal (TP) and non-treponemal (NT) antibodies on a single test device. SyphiDuo™ is now available for partnering and distribution across the world including Africa, Asia, Latin America, and other low- and middle-income countries (LMICs), where pregnant women bear a disproportionately high burden of syphilis.

According to the World Health Organization (WHO), an estimated 8 million adults acquired syphilis in 2022. Syphilis during pregnancy remains one of the leading preventable causes of stillbirth, neonatal death, prematurity, and congenital infection, resulting in approximately 700,000 cases of congenital syphilis and 390,000 adverse pregnancy outcomes each year. In many LMICs, 1–5% of pregnant women attending antenatal clinics are infected with syphilis, representing millions of pregnancies annually that require timely screening and treatment to prevent mother-to-child transmission.

Although syphilis can be effectively treated with inexpensive antibiotics, many pregnant women remain undiagnosed because current screening strategies often require multiple tests with back-and-forth clinic visits or laboratory infrastructure that is unavailable in resource-limited settings. Loss of follow-up or delayed diagnosis frequently results in missed treatment opportunities, avoidable adverse pregnancy outcomes, and continued transmission.

To support a “Test and Treat” strategy, SyphiDuo™ combines the traditional two laboratory-based tests into a single rapid test, enabling healthcare providers to make immediate treatment decisions during the patient’s first visit, eliminating the need of return for multiple tests or complex testing algorithms.

Designed for decentralized healthcare settings, SyphiDuo™ delivers rapid results from fingerstick whole blood, venous whole blood, or serum without the need of laboratory instrumentation or specialized personnel. By combining two clinically complementary assays into a single affordable test, SyphiDuo™ simplifies antenatal screening workflows, reduces overall testing costs, minimizes patient loss to follow-up, and improves access to high-quality diagnostics in primary healthcare clinics and other resource-limited settings.

In its guideline published in July 2024, the WHO specifically made a strong recommendation for the use of dual TP/NT RDTs in syphilis testing. The WHO also published a Target Product Profile (TPP) for such tests in 2021. Multiple clinical studies have shown that as compared with standard laboratory serological tests, SyphiDuo™ had a sensitivity and specificity of 99.4% and 97.4%, respectively to detect TP, and a sensitivity and specificity of 100.0% and 97.0%, respectively to detect NT at a titer of 1:8 or higher. SyphiDuo™ is thus one of the first dual-marker syphilis RDTs exceeding the preferred performance requirements set in the WHO TPP.

“Syphilis remains a preventable tragedy for hundreds of thousands of mothers and newborns every year,” said Jay Z. Zhang, Executive Chairman of Shuwen Biotech. “We believe SyphiDuo™ can significantly simplify screening workflows, improve same-day treatment rates, and strengthen global efforts to eliminate congenital syphilis, particularly in resource-limited settings. As an affordable solution with superior diagnostic performance, SyphiDuo™ will help to make high-quality syphilis screening accessible to millions more women worldwide.”

Shuwen Biotech is actively seeking distribution and commercialization partners throughout Africa, Southeast Asia, South Asia, Latin America, and other emerging markets, as well as those in the developed world. The company is committed to collaborating with ministries of health, international organizations, maternal health programs, non-governmental organizations, and commercial partners to expand access to SyphiDuo™ and accelerate progress toward the global elimination of congenital syphilis.

About SyphiDuo™
SyphiDuo™ is a next-generation point-of-care rapid diagnostic test that simultaneously detects treponemal (TP) and non-treponemal (NT) antibodies using a single test cassette. Designed for use with fingerstick whole blood, venous whole blood, or serum, the test delivers rapid results without laboratory instrumentation. By combining two clinically complementary biomarkers in one affordable test, SyphiDuo™ enables efficient test-and-treat programs while reducing the costs associated with multiple tests, repeat patient visits, and unnecessary referrals.

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 portfolio of novel diagnostics in women’s health, spanning pre-eclampsia, sexually transmitted infections, breast cancer, and precision medicine. 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 Z. Zhang
Shuwen Biotech Co. Ltd.
info@shuwendx.com
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