Benzinga | Nov 16, 2021 04:06PM EST

Chembio Reports Submission Of Emergency Use Authorization For New SARS-CoV-2 Antigen Test

Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced the submission of an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for the new DPP SARS-CoV-2 Antigen test.

Previously, 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 assist in developing a COVID-19 point-of-care antigen test system using Chembio's proprietary DPP technology and requesting FDA EUA for the test system. The DPP SARS-CoV-2 Antigen test system has been designed to detect SARS-CoV-2 antigens in only 20 minutes. The DPP SARS-CoV-2 Antigen test system is now designed to use a minimally invasive nasal swab and be read visually or with a DPP Micro Reader or DPP Micro Reader 2 optical analyzer.

"We are steadfast in our commitment to leveraging our proprietary DPP technology to address COVID-19 testing needs, while offering a broad portfolio of testing solutions for a variety of healthcare customers. Rapid point-of-care testing has proved to be one of the best tools for mitigating the spread of the virus as rapid results enable healthcare workers to initiate on-site patient management," said Richard Eberly, Chembio's President and Chief Executive Officer. "We are pleased to have completed the submission which we view as a testament to our team's dedication and technical expertise. Again, we would like to extend our gratitude to BARDA for their continued guidance and support throughout this process. We look forward to working closely with BARDA and the FDA to bring patients and health care workers the benefits of the DPP SARS-CoV-2 Antigen test system."