HAUPPAUGE, N.Y., Sept. 06, 2022 (GLOBE NEWSWIRE) — Chembio Diagnostics, Inc. (Chembio) (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced it was awarded a $3.2 million contract from the Centers for Disease Control and Prevention (CDC) for the development and clinical validation of a rapid point-of-care (POC) diagnostic test for syphilis.
Chembio will undertake to develop a syphilis test and confirm assay based on its Dual Path Platform (DPP) technology and proprietary DPP Micro Reader II. The assay will be intended to simultaneously and separately detect treponemal and nontreponemal IgM and IgG antibodies. The test should require only 10 µL of fingerstick blood, serum, or plasma and produce results in under 20 minutes.
Chembio has previous experience in the field of rapid syphilis diagnostics through its successful development, validation, and commercialization of DPP HIV-Syphilis. The Chembio DPP HIV-Syphilis Assay is a rapid serologic test for the detection of antibodies to HIV and/or the causative agent of syphilis, Treponema pallidum. Additionally, Chembio has worked to develop a DPP Syphilis Screen and Confirm test, using a CDC licensed reagent with improved liposomal preparation on the nontreponemal test line.
“We are excited to continue expanding our core sexually transmitted disease portfolio with the syphilis screen and confirm assay,” commented Javan Esfandiari, Chembio’s Chief Science and Technology Officer. “We look forward to developing a highly sensitive and highly specific test that will potentially enable physicians to diagnose and treat active syphilis in a timely manner. Early and reliable diagnosis and timely treatment can prevent transmission of syphilis as well as the development of severe complications. We are honored to have been selected by the CDC for this award.”
Syphilis infections continue to be a significant health problem and are particularly threatening in high-risk groups and in people who are pregnant, where congenital syphilis can severely affect pregnancy outcome and infant morbidity. According to the CDC, the rate of primary and secondary syphilis (the most infectious stages of the disease) has increased almost every year since the historic low in 2001–2002, increasing 25.4% during 2020–2021, according to preliminary data. The timely identification and treatment of syphilis can decrease the transmission to others and result in better patient outcomes.