Chembio Diagnostics Submits EUA Application for DPP SARS-CoV-2 Antigen Test System

Rapid Test Provides Results in Only 20 Minutes

HAUPPAUGE, N.Y., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostic company focused on infectious diseases, today announced the submission of an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the DPP SARS-CoV-2 Antigen test system, which has been designed to detect SARS-CoV-2 antigens in only 20 minutes. The DPP SARS-CoV-2 Antigen test system consists of a DPP SARS-CoV-2 Antigen test cartridge, a DPP Micro Reader optical analyzer and a minimally-invasive nasal swab.

“The antigen test system EUA submission is another example of the scientific expertise of our team and the flexibility of our DPP technology,” said Richard Eberly, Chembio’s President and Chief Executive Officer. “We are committed to leveraging this technology to offer a comprehensive COVID-19 testing portfolio. The DPP platform is ideally suited as a cost-effective system for rapid testing at the point of care and can help expand patient access to testing. Rapid antigen testing has proven to be one of the most effective methods for population screening and diagnosis available today. Offering both antibody and antigen testing using the same Micro Reader will enable clinicians to both diagnose and monitor COVID-19 infection status with Chembio products. Thank you to our team and to BARDA for their support throughout the development of the antigen system. We look forward to working with the FDA to achieve EUAs as soon as possible for the DPP SARS-CoV-2 Antigen test system and our previously submitted antibody test system.”

As defined by the U.S. Centers for Disease Control and Prevention, part of the U.S. Department of Health and Human Services (HHS), antigen tests are immunoassays that detect the presence of a specific viral antigen, which imply a current viral infection. Rapid antigen tests are commonly used in the diagnosis of respiratory pathogens, including influenza viruses and respiratory syncytial virus.

About the DPP Rapid Test Platform
Chembio’s proprietary DPP technology platform provides high-quality, rapid diagnostic results in 15 to 20 minutes using a small drop of blood from the fingertip or alternative samples. Through advanced multiplexing, the DPP platform can detect up to eight, distinct test results from a single patient sample, which can deliver greater clinical value than other rapid tests. For certain applications, Chembio’s easy-to-use, highly portable, battery-operated DPP Micro Reader optical analyzer then reports accurate results in approximately 15 seconds, making it well-suited for decentralized testing where real-time results enable patients to be clinically assessed while they are still on-site. Objective results produced by the DPP Micro Reader reduce the possibility of the types of human error that can be experienced in the visual interpretations required by many rapid tests.