Chembio Diagnostics Receives FDA Approval for DPP HIV-Syphilis System

First Rapid Test Approved in U.S. to Aid in Diagnosis of Both HIV and Syphilis from Single Patient Sample

HAUPPAUGE, N.Y., Oct. 02, 2020 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostic company focused on infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the Premarket Approval (PMA) application for the DPP HIV-Syphilis System. The system includes the DPP HIV-Syphilis assay, a multiplex single-use test, and the DPP Micro Reader optical analyzer, and is being offered in the United States immediately.

“The multiplex DPP HIV-Syphilis System represents a significant step forward in rapid testing for sexually transmitted diseases. This differentiated test provides clinicians with actionable information to improve patient care in critical areas, including co-infection and mother to child transmission,” said Richard Eberly, Chembio’s President and Chief Executive Officer. “We would like to thank the FDA for their effort throughout the approval process. This expansion of our product portfolio aligns directly with our diversification into high-value testing areas in the United States. Under the PMA, the DPP HIV-Syphilis System is approved for use by trained professionals in point-of-care (POC) and laboratory settings to aid in the diagnosis of HIV and syphilis infections. Activities to pursue a CLIA Waiver are ongoing.”

Co-infection rates of HIV and syphilis are on the rise and, according to the U.S. Centers for Disease Control and Prevention (CDC), individuals with an active syphilis infection have an estimated two-to-five-fold increased risk of contracting HIV if exposed to that virus. The CDC has also reported that 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% of cases and may result in stillbirth or infant death in up to 40% of cases. Congenital syphilis has increased by 185.3% from 2014 to 2018, consistent with the 165.4% increase in active syphilis infections among reproductive-aged women during the same period.

Congenital syphilis is a preventable disease that could be significantly reduced through effective prenatal testing and treatment of infected pregnant women. Chembio’s DPP HIV-Syphilis System assists clinicians in diagnosing HIV or syphilis while patients are still at a POC setting.

According to the U.S. Department of Health & Human Services, one in eight people living with HIV in the United States are unaware of their infection, and improving access to HIV testing can help more people learn their status so they can be connected to care and treatment. The CDC recommends that individuals at higher risk of HIV infection be tested at least annually.