CHEMBIO DIAGNOSTIC SYSTESMS INC., A SUBSIDIARY OF BIOSYNEX, ANNOUNCES DUAL FDA SUBMISSION OF DPP® SYPHILIS TnT ASSAY FOLLOWING BREAKTHROUGH DEVICE DESIGNATION
Medford, N.Y., USA / Strasbourg, France – January 22, 2026 – Chembio Diagnostic Systems, Inc., a wholly owned subsidiary of Biosynex, a leading point-of-care diagnostic company, today announced the dual submission of its DPP® Syphilis TnT (Treponemal/Non-Treponemal) Assay to the U.S. Food and Drug Administration (FDA) for review. The submission includes 510(k) premarket notification and a CLIA Waiver by Application.
The submission follows the FDA’s Breakthrough Device designation, granted in July 2025, recognizing the assay’s potential to address an urgent public health need and enables prioritized interaction and review with the agency to aid in the diagnosis and clinical management of syphilis.
Syphilis continues to rise across the United States, including alarming increases among pregnant women and underserved communities. Rapid and accurate diagnosis is essential to enable timely treatment and prevent serious complications, including congenital syphilis.
“Announcing this dual FDA submission represents an important milestone to address the growing burden of syphilis in the U.S.,” said Steven Sepulveda, Chief Strategy Officer at Chembio Diagnostics. “If cleared, the assay would represent the first CLIA-waived point-of-care tests designed to detect both treponemal and non-treponemal antibodies in a single patient encounter. This approach has the potential to reduce reliance on laboratory send-out testing and support more timely treatment decisions in appropriate care settings.”
The DPP® Syphilis TnT Assay is designed to simultaneously detect treponemal and non-treponemal total (IgM/IgG) antibodies in a single, rapid point-of-care test using fingerstick whole blood, plasma, or serum. The test delivers results in approximately 15 minutes. The test is intended for CLIA-waived use and is read using the DPP® Micro Reader II, which provides objective results to support use in decentralized clinical environments such as public health clinics, community testing programs, maternal health settings, and mobile outreach initiatives.
“The DPP Syphilis TnT Assay builds on the strength of our Dual-Path Platform technology to deliver accurate results across a range of care settings,” said Javan Esfandiari, President of Chembio Diagnostics. “By providing results for both treponemal and non-treponemal total antibodies in a single encounter, clinicians may be better positioned to make same-day treatment decisions. This dual submission reflects our long-term commitment to advancing point-of-care diagnostics that meet the needs of public health programs addressing the continued burden of syphilis.”
The FDA’s Breakthrough Devices Program is intended to expedite the development and review of technologies that may offer more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions. Chembio will continue to work closely with the agency throughout the review process for the DPP® Syphilis TnT Assay.
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About Chembio Diagnostic Systems, Inc.
Chembio Diagnostic Systems, Inc., a subsidiary of the Biosynex Group, is a leading diagnostics company focused on the development, manufacture, and commercialization of point-of-care tests for infectious diseases. The company’s proprietary DPP® technology platform delivers high-quality, accurate results within minutes, supporting rapid diagnosis and improved patient outcomes worldwide.
For more information, visit www.chembio.com.
About BIOSYNEX
Founded in 2005, the French laboratory BIOSYNEX is a leading health diagnostics group, specializing in rapid tests, biotherapy monitoring, and molecular biology.
As a forward-thinking player in the future of medicine, BIOSYNEX advocates for the improvement of healthcare pathways and offers innovative health solutions to a variety of users, including laboratories, hospitals, doctors, and the general public, aimed at enhancing overall patient care.
Following its significant contribution during the Covid-19 pandemic, BIOSYNEX has gained new international stature in the rapid diagnostics field, partly due to its dynamic external growth strategy. The Group now has research, production, and distribution subsidiaries in the United States, Europe, and Asia, supporting its two business units: BIOSYNEX PHARMACY and BIOSYNEX DIAGNOSTICS.
For the general public: The BIOSYNEX Pharmacy division, specializing in self-diagnostics and family health products, distributes a comprehensive range of well-established and recognized brands across a wide network of pharmacies and parapharmacies, focusing on prevention, diagnostics, and natural care.
For professionals: The BIOSYNEX Diagnostics division, a technology-driven business operating in high-growth sectors, develops and provides laboratories, hospitals, doctors, and nursing homes with in vitro diagnostic medical devices in the form of rapid diagnostic tests (RDTs and POC tests), molecular biology, and point-of-care (POC) products for screening, diagnosis, and prevention.
Based in Illkirch-Graffenstaden, Alsace, the BIOSYNEX Group employs over 500 people and has a presence in 95 countries. The Group achieved a turnover of €93 million in 2023. Listed on Euronext Growth Paris (FR0011005933 ALBIO), BIOSYNEX is eligible for PEA-PME.
For more information, visit www.biosynex.com.
