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FDA grants emergency approval for Utah company's COVID-19 test

Posted at 10:37 AM, Apr 06, 2020
and last updated 2020-04-06 23:30:00-04

SALT LAKE CITY — The FDA granted a Utah company "Emergency Use Authorization" to approve a new type of COVID-19 testing.

Co-Diagnostics, a Utah corporation, developed a test called Logix Smart Coronavirus COVID-19 Test to diagnose the disease by targeting a specific gene.

"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. Many experts agree that accessibility of widespread testing is an important element to ‘flattening the curve’ as U.S. cases of COVID-19 continue to rise, and that increased testing throughput is vital to achieve this objective," said Co-Diagnostics CEO Dwight Egan in a news release.

The company said each test takes two hours to complete and can process up to 48-patient samples at a time, allowing labs to run more samples while using less man power.

“We feel the most important thing isn’t necessarily the amount of time it takes to run each individual diagnostic, it’s really more of how many can be run in a certain amount of time,” said Andrew Benson, Co-Diagnostics’ head of corporate communications.

“At this point we all know people, either directly or indirectly, who have struggled to receive a test,” Benson continued. “The way to really get around that is to help increase the throughput of the labs that are testing for COVID-19, as well as to increase the number of labs that are able to test.”

The news release said the test uses fewer resources than other tests for diagnosing COVID-19.

"Co-Diagnostics believes the lower cost of reagents in the Company’s single-well test will help hospitals and laboratories to process more while paying less, benefiting healthcare providers and patients alike," the news release said.

With the FDA's approval, Co-Diagnostics can now sell its Logix Smart Coronavirus COVID-19 Test to certified clinical laboratories.