Co-Diagnostics, Inc. to Provide COVID-19 Tests to US CLIA Labs Following FDA Policy Change
The Company is in discussions with certain qualified CLIA laboratories who can use COVID-19 tests built on
“In addition to these efforts with US CLIA labs following the change in US policy, our CE-IVD Logix Smart™ COVID-19 test kit has already been shipped to countries on several continents, both for performance evaluation as well as for use as a diagnostic tool where its CE marking makes that possible.”
The policy change is a result of the FDA’s commitment to aggressively address the current coronavirus outbreak, and allows CLIA laboratories to use tests that have been developed and validated for detection or diagnosis of the novel coronavirus before the FDA has completed the review of the laboratories’ submission under Emergency Use Authorization (EUA) guidance. Prior to the chance in policy, all laboratories wishing to test for COVID-19 were required to complete their EUA submission and receive clearance from the FDA.
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Head of Investor Relations