Chembio slumps on delay of U.S. nod for coronavirus antibody test

 

• Chembio Diagnostics (NASDAQ:CEMI) is down 13% premarket on increased volume in response to its disclosure that the FDA will not prioritize its application for emergency use authorization (EUA) of its DPP SARS-CoV-2 IgM/IgG antibody blood test that is performed on its DPP Micro Reader.
• In a letter delivered to the company yesterday, the agency stated that, given the volume of EUA requests, it is prioritizing its review of the filings based on a range of factors such as the public health need for the product and its availability. In the case of the antibody combo test, it believes that authorization of the assay would have relatively limited impact on testing accessibility or capacity so it will not review the application at this time.
• Unsurprisingly, the company believes otherwise and plans to work with the agency to get its application into the review queue, adding that the response letter does not apply to its application for the DPP SARS-CoV-2 Antigen test system filed in October.
• https://seekingalpha.com/news/3641681-chembio-slumps-13-on-delay-of-u-s-nod-for-coronavirus-antibody-test