• Roche is 1st commercial coronavirus test maker to win FDA emergency use authorization

    • March 14, 2020
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    • Roche on Friday announced it received FDA’s emergency use authorization (EUA) for a swab sample test for the novel coronavirus. The Swiss pharma and diagnostics company expects to make “millions of tests a month” available in response to the pandemic.
    • The product, which runs on Roche’s cobas 6800/8800 high-throughput molecular testing systems, can deliver results in three and a half hours, the company said. In total, there are currently 827 of the systems distributed worldwide, over a hundred of which are in the U.S. A Roche spokesperson said the company has collaborated with CDC and is targeting its “limited supply” to large, national reference labs, along with some regional hospitals “in the most highly impacted areas.” The company will “continually assess this strategy as the situation develops,” the spokesperson said.
    • Roche is the first commercial test developer to achieve EUA status for a diagnostic test for SARS-CoV-2. In an update Friday, FDA Center for Devices and Radiological Health Director Jeff Shuren said more than 60 developers have worked with the agency on potential EUA submissions, and more than 30 labs have said they plan to begin testing under a recent FDA coronavirus policy allowing use of pre-EUA lab developed tests.

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