CHEMBIO DIAGNOSTICS, INC. (NASDAQ:CEMI) Files An 8-K Other Events
Item 8.01
CHEMBIO DIAGNOSTICS, INC. (NASDAQ:CEMI) Files An 8-K Other Events
On February 21, 2020, we received a “not approvable” letter from the U.S. Food and Drug Administration, or FDA, with respect to our pre-market approval, or PMA, submission on our DPP HIV-Syphilis multiplex test for commercial use in the United States. Our DPP HIV‑Syphilis System is a single-use, 15-minute screening test for the simultaneous detection of antibodies to HIV types 1 and 2 and Treponema pallidum, the bacteria that causes syphilis. The FDA’s letter indicates that the PMA submission was not approvable in its current form because of reproducibility issues at one of three test sites used in the submission.
In a separate communication, the FDA confirmed to us that the syphilis portion of the PMA submission was acceptable, as was data relating to the inclusion of the pregnant women.
On March 3, 2020, we issued a press release titled “Chembio Diagnostics Provides Update on Regulatory Status of DPP HIV-Syphilis System,” which describes our current actions and plans with respect to the FDA’s letter. A copy of the press release is included as Exhibit 99.1 to this report and is incorporated in this report by reference.
CHEMBIO DIAGNOSTICS, INC. Exhibit
EX-99.1 2 ex99_1.htm EXHIBIT 99.1 Exhibit 99.1 Chembio Diagnostics Provides Update on Regulatory Status of DPP HIV-Syphilis System Medford,…
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EX-99.1 2 ex99_1.htm EXHIBIT 99.1 Exhibit 99.1 Chembio Diagnostics Provides Update on Regulatory Status of DPP HIV-Syphilis System Medford,…
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About CHEMBIO DIAGNOSTICS, INC. (NASDAQ:CEMI)
Chembio Diagnostics, Inc. (Chembio), and its subsidiary, Chembio Diagnostic Systems, Inc., develop, manufacture, market and license rapid point-of-care diagnostic tests (POCTs) that detect infectious diseases. The Company’s products available are rapid tests for the detection of human immunodeficiency virus (HIV) 1/2 antibodies, and a multiplex rapid test for the detection of HIV and Syphilis antibodies. The HIV 1/2 rapid tests employ in-licensed and lateral flow technologies that are used with all blood matrices as samples, and are manufactured in a standard cassette format, a dipstick format and a barrel format. Its HIV 1/2 rapid antibody detection test incorporates the Dual Path Platform (DPP) POCT technology. The DPP HIV 1/2 Assay detects antibodies to HIV 1 and 2 in oral fluid samples, as well as in all blood matrices. The Company’s product pipeline includes a multiplex rapid test for earlier detection of HIV and a multiplex test that detects HIV and Syphilis specific antibodies.