- In November 2024, NOWDiagnostics launched nationwide retail distribution of its First To Know Syphilis Test. The self-test became available in thousands of U.S. pharmacies, retail stores, and online platforms such as Amazon. At an estimated cost of USD 30, the test offers an affordable and accessible at-home option amid rising syphilis cases
- In October 2024, Chembio Diagnostics promoted its point-of-care syphilis testing solutions at the 2024 SCASM (La Jolla, CA) and the National Conference on Correctional Health Care (Las Vegas, NV). The company showcased its DPP® rapid tests, including the HIV-Syphilis combo, highlighting onsite screening benefits for acute care and correctional health environments
- In October 2024, NOWDiagnostics and Labcorp announced a distribution partnership. Labcorp became the exclusive U.S. distributor of the First To Know Syphilis Test across clinical and professional settings. The 15-minute test is expected to reach healthcare providers by the end of 2024 and be made available to patients via Labcorp OnDemand in 2025
- In September 2024, Beckman Coulter announced FDA 510(k) clearance for its Access Syphilis assay. The two-step, chemiluminescent microparticle immunoassay detects total antibodies to T. pallidum (IgG/IgM) in serum or plasma and runs on Beckman’s Access analyzers. The ready-to-use liquid format supports both screening and confirmatory protocols
- In August 2024, NOWDiagnostics received FDA marketing authorization for its First To Know Syphilis Test, the first at-home, over-the-counter syphilis antibody test in the U.S. The test uses one drop of blood from a finger-prick to detect total T. pallidum IgG/IgM, delivering results in about 15 minutes. Clinical studies showed ~99.5% agreement on negatives and ~93.4% on positives compared to laboratory-based assays
- In August 2024, QuidelOrtho Corporation (formerly Ortho Clinical Diagnostics) obtained FDA 510(k) clearance for its VITROS® Syphilis assay. This automated chemiluminescent immunoassay, compatible with VITROS 3600/5600/XT 7600 analyzers, detects total antibodies to T. pallidum. It supports the CDC-recommended reverse-testing algorithm and enhances laboratory efficiency
- In February 2023, Chembio Diagnostics (Nasdaq: CEMI) announced the FDA CLIA waiver of its DPP HIV-Syphilis System. This is the first point-of-care lateral-flow multiplex assay cleared for simultaneous detection of HIV-1/2 and Treponema pallidum antibodies from a fingerstick (~10 μL) or plasma. The 15-minute test, used with Chembio’s DPP Micro Reader, enables rapid co-screening of HIV and syphilis, supporting earlier diagnosis and treatment
