March 17, 2020 / 10:55 AM / 19 days ago

Co-Diagnostics says new FDA policy to help expand use of COVID-19 test

(Reuters) - Co-Diagnostics Inc said on Tuesday the U.S. Food and Drug Administration’s new policy to expand availability of COVID-19 tests will allow the medical test maker’s tests to be distributed to a wide array of U.S. labs.

The agency said on Monday it would not object to commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting a so-called Emergency Use Authorization.

The agency also took steps toward speeding the development of coronavirus test kits by giving states the authority to approve tests developed in laboratories in the states.

Reporting By Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli

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