Utah company gets FDA approval for more COVID-19 testing in U.S.

A Utah diagnostics company which has already distributed its COVID-19 tests to Europe will now be able to make those same tests widely available in the United States.

CO-Diagnostics received approval from the FDA this week to allow its test kits for use by and marketed to a huge array of U.S. laboratories without first requiring Emergency Use Authorization.

 

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“The ramifications of this new FDA policy are significant for our company,” said Co-Diagnostics CEO Dwight Egan. “This change will quickly afford Co-Diagnostics even more opportunities to serve the needs of laboratories nationwide, as we plan an even larger role in responding to this pandemic. We applaud the FDA’s decision to recognize the dire need for increased access to high-quality COVID-19 tests, and to adapt as the situation demands in light of a public health emergency.”

In the past month, Co-Diagnostics has shipped its CE marked and research use Logix Smart COVID-19 test kits to Italy, German, the Philippines, Thailand, Australia, Paraguay, Ecuador, Israel, South Africa, and Canada. There have also been numerous shipments to customers and research institutions in the United State, Egan said.

Until now, the domestic shipments have been in line with FDA’s February policy change that allows U.S. laboratories to use the company’s COVID-19 test kits but only under certain conditions.

Egan said CO-Diagnostics kits offer quick and accurate results, which will aid laboratories in the United States meet the growing need of testing.

“Our cost-effective Logix Smart COVID-19 test has been designed to run on a variety of commercially available platforms, with easy-to-interpret results in under two hours,” Egan said. “We are confident in our ability to meet the growing demand for this diagnostic.”