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Utah company’s COVID-19 test gets FDA approval, set to produce 50K per day

Deseret News logo Deseret News 3/18/2020 Art Raymond
a person holding a bottle: A Co-Diagnostics COVID-19 testing kit is pictured in Salt Lake City on Tuesday, March 17, 2020. © Jeffrey D. Allred, Deseret News A Co-Diagnostics COVID-19 testing kit is pictured in Salt Lake City on Tuesday, March 17, 2020.

SALT LAKE CITY — Utah molecular diagnostics company Co-Diagnostics has earned emergency U.S. Food and Drug Administration approval of its COVID-19 test.

The company is ready to produce 50,000 tests per day from its Salt Lake City laboratory and has the capacity to manufacture an additional 100,000 tests per day from another facility in India. How many of these tests may be made available for Utah patients was not immediately clear, though a company spokesman said earlier this week that its capacity could “supply all of the testing needs in Utah and around us easily.”

The FDA greenlight on the test will allow the company to “aggressively expand its presence in the U.S. market,” according to a news release.

Co-Diagnostics had previously earned approval for its test from European health authorities and its test is already in use in Italy, Germany, the United Kingdom, Turkey, Greece, the Philippines, Thailand, Australia, Paraguay, Ecuador, Israel, South Africa and Canada, in addition to numerous shipments to customers and research institutions in the United States.

The company said U.S. shipments to date have been in accordance with the FDA’s policy change on Feb. 29 that allows certified U.S. laboratories to use the Co-Diagnostics COVID-19 test under certain conditions. Now, as a result of the change announced Tuesday night by the FDA, the company’s test kit will soon be available for use by and marketed to a wide array of U.S. laboratories, without first requiring Emergency Use Authorization.

Co-Diagnostics CEO Dwight Egan said the approval puts his company in a position to have positive impacts on the critical need for COVID-19 testing capacity in Utah, the U.S. and around the world.

“The ramifications of this new FDA policy are significant for our company, Egan said in a statement. “This change will quickly afford Co-Diagnostics even more opportunities to serve the needs of laboratories nationwide, as we play 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.”

This story will be updated as new information becomes available.


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