Shares of Chembio Diagnostics Inc. tumbled on Wednesday after the Food and Drug Administration declined to review the company's application for an emergency-use authorization for its DPP respiratory antigen panel.
The Hauppauge, N.Y., maker of medical tests said the agency is requiring the collection of more influenza A and B samples and the submission of a new application to proceed.
Chembio previously said it had encountered delays during clinical trials for the panel, which is designed to provide simultaneous detection of SARS-CoV-2, influenza A and influenza B antigens from a single patient specimen in about 20 minutes, due to the near absence of flu in the U.S. amid the Covid-19 pandemic.
The company said it had incorporated foreign-sourced influenza-positive samples preserved in viral transport media in its clinical data for panel in a bid to mitigate the impact of the low U.S. flu incidence.
In a filing late Tuesday with the Securities and Exchange Commission, Chembio said it could give no assurance that it would be able to compile the additional specimens requested by the FDA in a timely manner or at all, or that it would be able to submit a new emergency-use-authorization.
Chembio shares were recently changing hands at $1.34, down 14%, after hitting a 52-week low of $1.22 earlier in the session. The stock is down more than 70% this year.
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