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Chembio Diagnostics Slides After FDA Declines to Review EUA -Breaking

by Mike Robinson

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© Reuters.

Sam Boughedda

Investing.com — Chembio Diagnostics Inc (NASDAQ:) shares fell over 20% Wednesday after it revealed in a regulatory filing that the U.S. Food and Drug Administration declined to review the company’s application for emergency use authorization for its DPP Respiratory Antigen Panel.

Chembio shares currently trade around $1.30. This is 16.6% less than Tuesday’s close. 

DPP Respiratory Antigen Panel can detect Influenza A and Influenza B from one patient’s nasal sample.

According to Chembio’s analysis, FDA’s declining performance is due to delays in clinical trials that were caused by a lack of influenza in the United States. Due to this, they had to add “foreign source influenza-positive” samples.

Chembio was told by the FDA that it needed to collect Influenza A samples from prospective donors and submit an EUA request.

Chembio stated that they cannot guarantee that the samples will be collected in time or that the company will submit the EUA.

The comments made by Chembio may have caused the shares of the company to plummet, but Bruce Jackson, Benchmark analyst said that this news will not impact his near-term expectations for the stock. This is due mainly to orders coming from overseas.

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