Hauppauge, N.Y.-based Chembio said in a news release that the contract will support the development of and pursuit of FDA emergency use authorization (EUA) for its rapid, multi-plex DPP respiratory antigen panel point-of-care testing system ahead of the upcoming flu season.
The contract also supports preparation for a potential FDA 510(k) clearance for the rapid DPP SARS-CoV-2 antigen test that the company has been submitted for EUA.
The DPP respiratory antigen test is designed for simultaneous, discrete and differential detection of influenza A, influenza B and SARS-CoV-2 antigens from a single respiratory specimen. It is touted as capable of providing results in approximately 20 minutes on Chembio’s DPP Micro Reader analyzer.
“We are honored to again partner with BARDA and appreciate their support as we endeavor on the shared mission to expand and decentralize COVID-19 testing,” Chembio president & CEO Richard Eberly said in the release. “The DPP technology is highly versatile, and these new product and regulatory objectives illustrate our commitment to offering virus detection for diagnosis at the point-of-care. We believe rapid, point-of-care tests can improve clinical outcomes and play a major role in combating this ongoing pandemic, especially during the upcoming flu season.”
In June, the FDA revoked the EUA for Chembio’s IgM/IgG SARS-CoV-2 serological antibody test that received authorization in March as a fingerstick-style test designed to use the company’s MicroReader 1 and MicroReader 2 analyzers to detect IgM and IgG antibodies and offer results within 15 minutes.