March 17, 2020 / 10:21 PM / 17 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 the availability of COVID-19 tests would 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 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.

Lab test developers are working with the FDA for approval and the agency has so far approved diagnostic tests made by companies including Roche Holdings AG and Thermo Fisher Scientific Inc.

Medical device maker Becton Dickinson and Co said on Monday that it was in talks with the FDA for emergency approval of a high-volume automated test for the coronavirus. It is partnering with molecular diagnostics company BioGX Inc.

“There is significant demand for testing,” said Nikos Pavlidis, vice president of molecular diagnostics and women’s health at Becton Dickinson. “The FDA is actively reviewing and discussing the application as we speak.”

Reporting by Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli and Peter Cooney

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