HAUPPAUGE, N.Y., Nov. 28, 2022 (GLOBE NEWSWIRE) — Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced the submission to the U.S. Food and Drug Administration (FDA) for a Clinical Laboratory Improvement Amendments (CLIA) waiver for the DPP HIV-Syphilis System.
“We are pleased to communicate that our DPP HIV-Syphilis System has been submitted to FDA for CLIA waiver. Upon receipt of CLIA waiver, we believe this will represent a large step forward in rapid testing for sexually transmitted infections. We appreciate the collaboration with the FDA on this submission and look forward to continued dialog regarding our CLIA waiver application,” said Richard L. Eberly, Chembio’s President and Chief Executive Officer.
Co-infection rates of HIV and syphilis are on the rise, according to the CDC, and 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 contracted the disease during the four years prior to 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 is a preventable disease that could be significantly reduced through effective prenatal testing of women of childbearing age and treatment of infected pregnant women.
Chembio’s DPP HIV-Syphilis System assists clinicians in diagnosing both HIV and syphilis while patients are still under care at the testing location. The System is a multiplex, single-use, 15-minute test that is designed, in combination with our Micro Reader analyzer, to simultaneously detect antibodies to HIV types 1 and 2 and Treponema pallidum, the bacteria that causes syphilis. The test uses a small, 10-microliter sample of fingerstick whole blood, venous whole blood, or plasma.
About the DPP Rapid Test Platform
Chembio’s proprietary DPP technology platform provides high-quality, rapid diagnostic results in 15 to 20 minutes using a small drop of blood from the fingertip or alternative samples. Through advanced multiplexing, the DPP platform can detect up to eight, distinct test results from a single patient sample, delivering greater clinical value than other rapid tests. For certain applications, Chembio’s easy-to-use, highly portable, battery-operated DPP Micro Reader optical analyzer then reports accurate results in approximately 15 seconds, making it well-suited for decentralized testing where real-time results enable patients to be clinically assessed while they are still on-site. Objective results produced by the DPP Micro Reader reduce the possibility of the types of human error that can be experienced in the visual interpretations required by many rapid tests.
Chembio’s portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA). Additionally, DPP-based tests have received regulatory approvals from the World Health Organization, CE-Mark, ANVISA, and other global organizations, where they aid in the detection and diagnosis of several other critical diseases and conditions.
All DPP tests are developed and manufactured in the United States and are the subject of a range of domestic and global patents and patents pending.