Chembio Diagnostics Announces CE Mark for DPP SARS-CoV-2 Antigen and IgM/IgG Test Systems

Enters Exclusive U.K. and Ireland Distribution Agreement with Luas Diagnostics

HAUPPAUGE, N.Y., Jan. 14, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostic company focused on infectious diseases, today announced the CE mark for the DPP SARS-CoV-2 Antigen and IgM/IgG test systems, providing regulatory approval to register and market both test systems in the European Union and other geographies that accept the CE mark. The Company also announced that it has entered into a distribution agreement with Luas Diagnostics, which will commence system sales immediately while serving as the exclusive commercial partner for all of Chembio’s products in the United Kingdom and Ireland.

“Having the CE mark for both COVID-19 test systems is indicative of the strong performance and reliability of the DPP system. These tests can assist clinicians across Europe with the diagnosis and management of patients and understanding virus exposure levels in their communities through testing in a variety of point-of-care settings,” stated Richard Eberly, Chembio’s President and Chief Executive Officer. “Partnering with Luas Diagnostics expands our global commercial footprint in the important markets of the United Kingdom and Ireland. We are very excited to offer our entire portfolio of products through this highly respected and connected organization.”

The DPP SARS-CoV-2 Antigen test system utilizes a DPP SARS-CoV-2 Antigen test cartridge, a DPP Micro Reader optical analyzer and a minimally-invasive nasal swab to detect SARS-CoV-2 antigens in only 20 minutes. Rapid antigen tests are commonly used in the diagnosis of respiratory pathogens.

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, DPP Micro Reader analyzers. The DPP platform’s ability to provide objective results can aid clinicians in avoiding the human interpretation errors associated with visual readings of traditional lateral flow tests.