Chembio +16% as it expects FDA test approval

Chembio Diagnostics (NASDAQ:CEMI) is up 15.8% after hours following its update on an FDA submission of its DPP HIV-Syphilis test.

The company is anticipating FDA approval of the system (including the HIV-Syphilis test and DPP Micro Reader) during the first quarter, it says.

The system is a single-use 15-minute screening test using a 10-microliter fingerstick sample of whole blood, venous whole blood or plasma.

“Our clinical study, which included the prospective enrollment of over 2,500 subjects, demonstrated that the DPP HIV-Syphilis System met the performance requirements established with the FDA,” says CEO John Sperzel.

https://seekingalpha.com/news/3529410-chembioplus-16-expects-fda-test-approval