A point-of-care diagnostic company Chembio Diagnostics, Inc. (Nasdaq: CEMI) which works on infectious diseases has made an initiation of the notification process and submission of an application to the Food and Drug Administration (FDA) of U.S. on the Emergency Use Authorization (EUA) for DPP SARS-CoV-2 IgM/IgG, its new rapid antibody test system.
New antibody test system has ability to provide the results in 15 minutes with the use of finger stick, venous whole blood, plasma, serum samples and Micro Reader 1 or Micro Reader 2 analyzers developed by Chembio Germany. Upon approval, the company will provide testing solution to the patients and clinicians across the healthcare system.
Chembio Diagnostics says it has accomplished its objectives in the the process of new DPP SARS-CoV-2 IgM/IgG test system’s development and validation. The company focused Submission of the EUA application for this test system has been the
On a market demand for the additional rapid tests majorly offering the ability to decentralize testing locations, the company has worked on priority basis for EUA application Submission for this test system.
Chembio’s President and CEO, Richard Eberly said, “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.” He added further, “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.”