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Utah company’s COVID-19 test gets FDA go-ahead, set to distribute 50K per day

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A Co-Diagnostics COVID-19 testing kit is pictured in Salt Lake City on Tuesday, March 17, 2020.

Jeffrey D. Allred, Deseret News

SALT LAKE CITY — Following a rule change instituted by the U.S. Food and Drug Administration Tuesday night, Utah molecular diagnostics company Co-Diagnostics has been cleared to distribute 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 changes that greenlighted distribution of the test will allow the company to “aggressively expand its presence in the U.S. market,” according to a news release.

While the new tests are set to come online, an ongoing dearth of reagent chemicals needed for another part of the COVID-19 testing procedure that requires “extraction kits” continues to hinder testing volumes and will likely impact how many of the new Co-Diagnostics test can be put to use.

In an online town hall hosted Wednesday afternoon by Utah tech advocacy group Silicon Slopes, Lt. Gov. Spencer Cox, who heads up the state’s COVID-19 Task Force, said the news of the changes that allowed Co-Diagnostics tests to be distributed was welcome, but obstacles still remained to increasing Utah’s testing capacity.

“They don’t make the reagent,” Cox said. “I talked specifically with Co-Diagnostics about that today.”

“But we’ve got a line on 10,000 of those (extraction kits). We wired the money today. Our hope is over the next two or three days we’ll get those kits and match them up with the tests,” he said.

Cox said ARUP Laboratories was now processing some 300 COVID-19 tests a day but was also being limited by reagent availability.

In a statement, Co-Diagnostics said it was working with Cox’s team to help track down the additional materials needed to amp up the state’s testing capacity and allow for greater use of the tests it was putting out.

“While securing extraction kits on behalf of customers is typically not part of our process, in order to help the state of Utah increase testing capacity, Co-Diagnostics is working closely with the governor’s office and our supply network to help source that particular component, starting with 10,000 extraction kits that are already ordered and on the way,” the statement read.

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’ test under certain conditions. As a result of the change announced Tuesday night by the FDA, the company’s test kit will soon be available for use by a wide array of U.S. laboratories, without first requiring emergency use authorization.

Co-Diagnostics CEO Dwight Egan said the rule change 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.”

Correction: An earlier version described the FDA decision as an approval, but a Co-Diagnostics representative clarified that the permission to distribute its COVID-19 test in the U.S. came via a rule change, not a formal approval under the FDA’s emergency use guidelines.