Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced that it has submitted a De Novo/510(k) Request to the U.S. Food and Drug Administration (FDA) for the DPP SARS-CoV-2 Antigen test system.
Chembio received an award from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, to support development of a COVID-19 point-of-care antigen test system using Chembio’s proprietary Dual Path Platform (DPP) technology. BARDA support included funding for the completion of clinical studies and preparation of a De Novo/510(k) submission for the rapid DPP SARS-CoV-2 Antigen test system.
The DPP SARS-CoV-2 Antigen test system is designed to detect SARS-CoV-2 antigens in only 20 minutes, using a minimally invasive nasal swab and read with a DPP Micro Reader or DPP Micro Reader 2 optical analyzer.
“The De Novo/510(k) Request for the DPP SARS-CoV-2 Antigen test system reflects our long-term strategy and commitment to deliver rapid, decentralized COVID testing solutions and broaden our portfolio of products in other disease categories that require rapid results for the U.S. market,” said Richard Eberly, Chembio’s President and Chief Executive Officer. “We would like to thank BARDA for their collaborative efforts in the development of both our COVID-19 tests and the respective regulatory submissions. We are hopeful for a straightforward review process with the FDA in order to offer healthcare providers additional testing solutions to support the evolving needs of the pandemic.”
