Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostic company focused on infectious diseases, today announced its initiation of the notification process and submission of an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its new rapid antibody test system, DPP SARS-CoV-2 IgM/IgG.

“We are pleased to have accomplished all of our objectives in the development and validation of the new DPP SARS-CoV-2 IgM/IgG test system,” stated Richard Eberly, Chembio’s President and Chief Executive Officer. “Submission of the EUA application for this test system has been the top priority for our organization because we understand there is a large need in the market for additional rapid tests – especially ones that offer the ability to decentralize testing locations. We are excited to offer a solution to patients and clinicians across the healthcare system that addresses these needs.”

The DPP SARS-CoV-2 IgM/IgG test system detects antibodies to the Spike Receptor Binding Domain in the blood that the body produces in response to a COVID-19 infection. Objective results can be obtained within 15 minutes using finger stick, venous whole blood, plasma, or serum samples, and Chembio’s cost-effective, highly portable, battery-powered Micro Reader 1 or Micro Reader 2 analyzers that are produced by Chembio Germany. The DPP platform’s ability to provide objective, numerical results can aid clinicians in avoiding the human interpretation errors associated with visual readings of traditional lateral flow tests.

IgM and IgG antibody test results assist clinicians in determining current or past exposure to the COVID-19 virus. The results and data from the test can contribute to improved clinical outcomes through the management of individual patients, as a population surveillance tool, and to potentially evaluate immune responses to anticipated vaccine administration.


Source: Company Press Release