NEW YORK – Chembio Diagnostics has obtained a CLIA waiver from the US Food and Drug Administration for its DPP HIV-Syphilis System, the firm announced on Friday.
The single-use, dual-target test detects HIV 1/2 and Treponema pallidum, the bacteria that causes syphilis, in 15 minutes using fingerstick blood, venous whole blood, or plasma. It can also be stored at room temperature and has a shelf life of two years. The test received premarket approval from the FDA in 2020.
An evaluation of the DPP HIV-Syphilis System in 2021 showed sensitivity and specificity of the HIV test was 96.8 percent and 99.3 percent, respectively, and sensitivity and specificity of the syphilis test was 85.7 percent and 100 percent, respectively.
"We are excited that the 200,000+ CLIA-waived, point-of-care testing sites in the US now have access to the DPP HIV-Syphilis System where its use can help save lives and minimize the spread of both HIV and syphilis," Richard Eberly, Chembio's president and CEO, said in a statement.
Chembio was acquired by French rapid test maker BioSynex for $17.2 million earlier this month.
Active syphilis infection increases the risk of contracting HIV by two- to fivefold, and untreated syphilis in pregnant women who acquired the disease during the four years before delivery can lead to infection of the fetus in up to 80 percent of cases and may result in stillbirth or infant death in up to 40 percent of cases, according to the US Centers for Disease Control and Prevention.
Recent CDC sexually transmitted disease surveillance data also show that STDs have increased for the sixth consecutive year, Eberly noted, adding, "The DPP HIV-Syphilis System offers actionable information to better manage two of the most critical threats posed by syphilis infections: the potentially lethal mother-to-child transmission and the increased risk of contracting HIV."
Chembio also recently received $3.2 million from the CDC to develop a rapid point-of-care test to screen for and confirm active syphilis.