FDA AWARDS BREAKTHROUGH DEVICE STATUS TO THE DPP® SYPHILIS TnT ASSAY

FOOD AND DRUG ADMINISTRATION AWARDS BREAKTHROUGH DEVICE STATUS TO THE DPP® SYPHILIS TnT ASSAY 

Medford, N.Y. USA / Strasbourg, France – July 29, 2025 – Chembio Diagnostic Systems, Inc., a subsidiary of Biosynex and a leader in point-of-care diagnostics, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its DPP® Syphilis TnT (Treponemal/Non-Treponemal) Assay, a rapid test designed to aid in the diagnosis of active syphilis at the point of care.

“We are proud to receive another Breakthrough Device designation from the FDA, this time for our syphilis test,” said Steven Sepulveda, Chief Strategy Officer at Chembio Diagnostics. “Syphilis continues to rise at alarming rates across the U.S., and the ability to diagnose patients accurately and immediately at the point of care—particularly in high-prevalence or underserved communities—is critical to controlling the epidemic.”

This is the second Breakthrough Device designation awarded to Chembio this month. On July 17, 2025, the FDA granted the same designation to the company’s SURE CHECK® HIV Self-Test, reinforcing Chembio’s momentum in advancing diagnostic tools that serve unmet public health needs.

The DPP® Syphilis TnT Assay is designed to detect both treponemal and non-treponemal total (IgM/IgG) antibodies in a single test using a variety of sample types, including fingerstick whole blood, plasma, or serum. The test produces results in approximately 15 minutes and is intended for CLIA-waived use, making it particularly well suited for decentralized settings such as public health clinics, mobile outreach units, and community testing programs. The test is read using Chembio’s proprietary Microreader II for DPP TnT, a key component of the system enabling accurate point-of-care interpretation.

By incorporating both antibody types into one cartridge, the assay is designed to support diagnostic workflows that may benefit from consolidated testing in a single patient encounter—streamlining the process where timely results are essential.

“The DPP® Syphilis TnT Assay was developed using Chembio’s proprietary dual-path platform technology, which is engineered to enable high sensitivity and specificity in a user-friendly, CLIA-waived format,” said Javan Esfandiari, President of Chembio Diagnostics. “The ability to have rapid test results for both non-treponemal and treponemal total (IgM/IgG) antibodies offers significant advantage allowing for same-day diagnosis and treatment. This designation further validates the clinical impact of our technology and the importance of making effective testing solutions accessible to those who need them most.”

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 to advance the DPP® Syphilis TnT Assay through the regulatory process.

See also FDA Awards Breakthrough Device Status to the SURE CHECK® HIV Self-Test