NEW YORK – Chembio Diagnostics said on Friday that the US Food and Drug Administration has provided premarket approval for the firm's DPP HIV-Syphilis System.
The system includes the multiplex Dual Path Platform (DPP) HIV-Syphilis assay and the DPP Micro Reader optical analyzer. It will be offered in the US immediately as a result of the FDA approval, the Hauppauge, New York-based company said.
"This differentiated test provides clinicians with actionable information to improve patient care in critical areas, including coinfection and mother to child transmission," Chembio President and CEO Richard Eberly said in a statement. "This expansion of our product portfolio aligns directly with our diversification into high-value testing areas in the United States."
The company noted that coinfection rates of HIV and syphilis are ticking up. People with active syphilis infection have a two- to fivefold increased risk of contracting HIV if exposed to the virus, Chembio said, citing statistics from the US Centers for Disease Control and Prevention.
The DPP HIV-Syphilis multiplex, single-use immunoassay system provides results in 15 minutes and detects antibodies to HIV types 1 and 2 as well as to Treponema pallidum, which causes syphilis. A 10-microliter sample of fingerstick blood, venous blood, or plasma is used for testing.