Biosynex Achieves Breakthrough Device Status for Its Syphilis Test

Biosynex SA announces that the FDA has granted Breakthrough Device status to its DPP® Syphilis TnT test. This rapid test, developed by Chembio Diagnostic Systems Inc., a subsidiary of Biosynex, enables the diagnosis of syphilis in decentralized settings. It effectively distinguishes between active infections and treated syphilis. Currently in the final stages of clinical validation, the device is intended for commercialization in the United States.

This FDA decision follows a similar designation granted to Chembio's SURE CHECK® HIV self-test in June. The DPP® Syphilis TnT test uses different specimen types to provide results in 15 minutes. It is suitable for public health clinics and mobile units. The device contributes to rapid and accurate care, while improving public health management.