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Co-Diagnostics COVID-19 Test Gets FDA Emergency Use Authorization

Co-Diagnostics COVID-19 Test Gets FDA Emergency Use Authorization

Co-Diagnostics Inc (NASDAQ: CODX) shares are getting boost on Monday.

The positive reaction is in the wake of an announcement from the company that its Logix Smart Coronavirus COVID-19 Test has received Emergency Use Authorization from the U.S. Food and Drug Administration. The authorization allows the test to be used by clinical labs certified under Clinical Laboratory Improvement Amendments, or CLIA, to detect the presence of the new coronavirus – SARS-CoV-2 – that causes COVID-19.

The company said the test is now available for purchase from its Utah-based ISO-13485:2016 certified facility.

The test uses Co-Diagnostics' patented CoPrimer technology to target the RdRp gene of the virus. The technology has helped it design a highly-specific, single-well PCR test, allowing higher throughput over tests that require multiple wells. The company also highlighted the lower cost of reagents used in its single-well test.

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"We believe that this authorization confirms the quality and performance of our COVID-19 test, and that it is a significant step in opening more doors and helping this test to reach an even wider audience," said Dwight Egan, CEO of Co-Diagnostics.

The Salt Lake, Utah-based company announced plans to develop a test to detect SARS-CoV-2 in late January.

The test was launched Feb 6, and the first sale was made to the international market Feb. 10. The test received CE mark authorization Feb. 24, allowing it to be sold in the European market.

The company in March said a change in FDA policy of allowing the sale of the test to labs under the CLIA ahead of EUA, will allow it to rapidly expand in the domestic market.

In pre-market trading, Co-Diagnostics shares were rallying 31.95% to $10.82.

Photo courtesy of Co-Diagnostics.


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