Benzinga | Dec 7, 2020 11:34AM EST

Chembio Diagnostics In Friday SEC Filing Said The FDA Ruled The Co's 'IgM/IgG' Emergency Use Authorization Request Is 'Not A Priority;'

On December 3, 2020, we received from the FDA a letter responding to the request we submitted in September 2020 for an emergency use authorization, or EUA, for the DPP SARS CoV-2 IgM/IgG with DPP Micro Reader, which we refer to as the IgM/IgG EUA, intended for use in the detection of antibodies to SARS-CoV-2. The response letter states that, given the volume of EUA requests it has received, the FDA is prioritizing review of EUA requests for tests, taking into account a variety of factors such as the public health need for the product and the availability of the product. The response letter further states that the FDA has determined that review of the IgM/IgG EUA request is not a priority because, for example, authorization of the test would have relatively limited impact on testing accessibility or testing capacity, and therefore the FDA has declined to review the IgM/IgG EUA request at this time.



We intend to work with the FDA to seek to establish priority for our IgM/IgG EUA, based on our belief that the DPP SARS CoV-2 IgM/IgG with DPP Micro Reader would increase testing accessibility. We cannot assure you, however, that we will be successful in our efforts to obtain FDA review of our IgM/IgG EUA or that FDA authorization of the IgM/IgG EUA will ever be obtained.



The response letter received with respect to our IgM/IgG EUA has no effect on our pending request, which we submitted in October 2020, for an EUA for the DPP SARS-CoV-2 Antigen test system.