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Investing.com — Chembio Diagnostics Inc (NASDAQ:CEMI) 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 are currently trading around the $1.30 mark, more than 16.6% below Tuesday’s close.
The DPP Respiratory Antigen Panel is a test system designed to detect Influenza A, Influenza B, and SARS-CoV-2 antigens from a single patient sample using a nasal swab.
The FDA’s decline, according to Chembio, stems from clinical trials in which the company encountered delays due to a “near absence of influenza” in the United States. As a result, the company had to include “foreign-sourced influenza-positive samples.”
However, the FDA told Chembio that to proceed, it would need to prospectively collect Influenza A and B samples and then submit a new EUA application.
Furthermore, Chembio said that it cannot confirm it will be able to collect the new samples in a timely manner or at all and cannot confirm that it will be able to submit a new EUA “at any specific time in the future or at all.”
While the comments from Chembio have caused its shares to tumble, Benchmark analyst Bruce Jackson said the news does not affect his near-term estimates for the stock, which is mainly driven by orders from outside of the U.S.
