Hauppauge, New York-based Chembio Diagnostics announced on Thursday that it has received CE marking for its DPP SARS-CoV-2 Antigen and IgM/IgG test systems, enabling their marketing in the European Union and other regions that accept the designation.
The company also announced that it has entered into a distribution agreement with Guildford, UK-based Luas Diagnostics, which will commence system sales and serve as the exclusive commercial partner for all Chembio products in the UK and Ireland.
The DPP SARS-CoV-2 Antigen test system utilizes a DPP SARS-CoV-2 Antigen test cartridge, DPP Micro Reader optical analyzer, and nasal swab to detect SARS-CoV-2 antigens in 20 minutes, Chembio said.
Its DPP SARS-CoV-2 IgM/IgG test system detects antibodies to the SARS-CoV-2 spike protein receptor binding domain in blood. Results can be obtained within 15 minutes using fingerstick, venous whole blood, plasma, or serum samples, and its portable DPP Micro Reader analyzers, Chembio said.
Luas Diagnostics CEO Brendan Farrell said in a statement that his firm sees significant “potential for Chembio’s rapid antigen and antibody products and DPP multiplex solutions, where testing can be performed rapidly, accurately, and with limited training.”
Though it has obtained CE marking, Chembio continues to have challenges in obtaining US Food and Drug Administration Emergency Use Authorizations for its coronavirus tests in the US.
In a document filed with the US Securities and Exchange Commission in December, the company said the FDA would not review an EUA submission for its SARS-CoV-2 antibody test because the agency FDA was prioritizing EUA requests based on public health need for the product and its availability, among other factors and determined Chembio’s test would have “relatively limited impact on testing accessibility or testing capacity.”