CHEMBIO DIAGNOSTICS, INC. (NASDAQ:CEMI) Files An 8-K Other Events
On June 16, 2020, we received a letter from the U.S. Food and Drug Administration, or FDA, notifying us that the FDA was revoking the Emergency Use Authorization, or EUA, granted in April 2020 with respect to our DPP COVID-19 System, which consists of our serological test for COVID-19 and one of our Micro Reader analyzers. As a result of this decision by the FDA, we may no longer distribute the DPP COVID-19 System.
The DPP COVID-19 System was one of the first antibody tests authorized by the FDA during the COVID-19 public health emergency. Based on the information that we submitted to the FDA at the time of authorization, the FDA concluded that our test system met the applicable “may be effective” standard for an EUA.
In its letter of June 16, 2020, the FDA stated that it had decided to revoke the EUA for the DPP COVID-19 System due to performance concerns regarding the sensitivity and specificity of our test system. According to the FDA, an independent evaluation of our test system by the National Institutes of Health’s National Cancer Institute, as well as other independent evaluations, showed (a) our test system generated a higher rate of false results than expected under our initial EUA request and our authorized labeling and (b) it is not reasonable to believe that our test system may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of our test system outweigh its known and potential risks.
We intend to continue working with the FDA with respect to the modification of the DPP COVID-19 System and of the revocation of the EUA for our test system.
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.
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