Shares of Chembio Diagnostics Inc. (Nasdaq: CEMI) are up 21.95% at $0.27 as of Tuesday’s premarket. We may then point to recent occurrences to offer a wider picture of the company as the CEMI stock increased in the lack of recent news.
How have recent events been at CEMI?
Chembio Diagnostics (CEMI) has disclosed the application for a Clinical Laboratory Improvement Amendments (CLIA) waiver for the DPP HIV-Syphilis System to the U.S. Food and Drug Administration (FDA).
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Chembio Diagnostics anticipated that the CLIA waiver would be a significant advancement in the field of quick testing for STDs. In working on its submission, CEMI valued the FDA’s participation, and it looked forward to keeping in touch about its request for a CLIA waiver. According to the CDC, co-infection rates between HIV and syphilis are increasing, and those who have current syphilis infections are at an estimated two- to five-fold higher risk of developing HIV if exposed to that virus.
The CDC has also noted that untreated syphilis can result in up to 80% of instances of fetal infection and up to 40% of cases of stillbirth or infant mortality in pregnant women who had the illness during the four years previous to delivery. Effective prenatal testing of women of reproductive age and treatment of pregnant women who are infected might dramatically lower the incidence of congenital syphilis, which is a condition that can be prevented.
How does the CEMI system work?
While patients are receiving care at the testing site, the DPP HIV-Syphilis System of Chembio Diagnostics (CEMI) enables doctors to diagnose both HIV and syphilis. When used with our Micro Reader analyzer, CEMI’s System is a multiplex, single-use, 15-minute test that is intended to simultaneously identify antibodies to HIV types 1 and 2 and the syphilis-causing bacterium Treponema pallidum. A little 10-microliter specimen of venous whole blood, plasma, or fingerstick whole blood is used in the test.
