Benzinga | Dec 8, 2021 06:19AM EST

Chembio Diagnostics Says O Dec. 1 Received Notice From FDA That FDA Would Require Additional Data Related To Clinical Laboratory Improvement Amendment Waiver Submission For DPP HIV-Syphilis Test System

Request for Additional Data Related to CLIA Waiver Submission for DPP HIV-Syphilis Test System



On December 1, 2021, we received notice from the U.S. Food and Drug Administration, or FDA, that the FDA would require additional data related to our Clinical Laboratory Improvement Amendment, or CLIA, waiver submission for the DPP HIV-Syphilis test system. We are in active discussions with the FDA in connection with the FDA's review of our submission and we intend to seek to comply with the FDA's request for additional data, but the process of seeking additional data will extend, for a currently undeterminable period, our process for seeking a CLIA waiver for the DPP HIV-Syphilis test system. We cannot assure you that we will be able to compile the additional data requested by the FDA in a timely manner or at all, and therefore we cannot assure you that a CLIA waiver will be granted with respect to the DPP HIV-Syphilis test system at any specific time in the future or at all.



Scheduled Expiration of BARDA Agreement



Our contract, which we refer to as the BARDA Agreement, dated December 2, 2020 with the Biomedical Advanced Research and Development Authority, or BARDA (part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response), expired in accordance with its terms on December 2, 2021. Under the BARDA Agreement, up to $12.7 million of awards were available from BARDA in order to assist us in (a) developing, and requesting an EUA from the FDA for, the DPP Respiratory Panel and (b) performing the clinical trials for and submitting the DPP SARSCoV2 Antigen test system to the FDA, for 510(k) clearance.



As of September 30, 2021 we had earned a total of $9.6 million in grant income under the BARDA Agreement, and from October 1, 2021 through December 2, 2021 we earned an additional $2.9 million of grant income under the BARDA Agreement. As a result, we earned $12.5 million of the $12.7 million available under the BARDA Agreement, with the remaining $0.2 million having not been earned because it was contingent on our receiving an emergency use authorization for the DPP Respiratory Panel by December 2, 2021.