Chembio Files Final Module of Premarket Approval Application With FDA for DPP(R) Point-of-Care HIV 1/2 Rapid Test

Chembio Diagnostics, Inc.

reports it has filed the final module of its Premarket Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for the Company's DPP® HIV 1/2 Assay. This module contains clinical data from the Company's 3,000-patient pivotal clinical trial for the product. "We are delighted to submit the final module of our PMA, and look forward to a favorable response from the FDA by year end in order to attain our ultimate goal to bring our DPP® HIV 1/2 Assay to market. Our pivotal study involved five clinical sites across the U.S. and was designed to include various patient groups as required by the FDA to support the sensitivity and specificity of the product across various demographics," commented Lawrence Siebert, Chembio's Chief Executive Officer. "With more than 1.1 million Americans estimated to be living with HIV and approximately 20% of them unaware they are infected with the virus, rapid HIV tests are playing a critical role in the U.S., as they have globally, to help identify those with HIV and to prevent disease transmission."