FDA grants Emergency Use Authorisation for Roche’s Coronavirus Test

Roche’s coronavirus test has been granted Emergency Use Authorization by the U.S. Food and Drug Administration, the Swiss pharma giant announced today.

Roche’s new Coronavirus Test available now

The cobas® SARS-CoV-2 Test, developed by Roche Holding (ticker: RHHBY) is going to be available in all markets accepting the CE mark. Roche’s advance is as per the FDA, the “first commercially distributed diagnostic test to receive an EUA during the COVID-19 outbreak.”

As President Donald Trump announced a national emergency today, due to the novel coronavirus outbreak, he noted that the FDA has approved the test developed by Roche and he expected 500,000 additional tests to be available next week. Trump also said that another test created by Thermo Fisher Scientific would be approved within 24 hours and deliver an extra 1.4 million tests next week, rising to 5 million coronavirus tests within a month.

In a press release published today the FDA explained,

“To expedite access to this test, FDA did not object to Roche pre-positioning its test so that labs could be ready to initiate testing immediately upon authorization of the EUA,…”.”Because of that pre-positioning, laboratories can immediately run tests on Roche’s high-volume platform, which will greatly increase national testing capacity.”

Unlike with public health laboratories, which largely conduct CDC-cleared tests, Roche’s commercial COVID-19 test can be used with many other laboratories across the US. Designed to run on a computerized diagnostic system developed by Roche, the test can be run on machines already installed at more than 100 labs across the States and will be available immediately.

The new test is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing. Reference laboratories and hospitals can run the test on Roche’s fully automated cobas® 6800 and cobas® 8800 Systems, which are widely available in the U.S. and globally. With Roche’s new coronavirus test, a patient could theoretically go to a hospital, have nasal and/or oral swabs collected, and then have those samples shipped over to an affiliated laboratory that can conduct the test.

Covid-19 test results in three hours

Roche claims the cobas 6800/8800 Systems which are used to perform the cobas® SARS-CoV-2 Test, provide test results in three and half hours. It has the fastest time-to-results with the highest throughput providing up to 96 results in about three hours and a total of 1,440 results for the cobas 6800 System and 4,128 results for the cobas 8800 System in 24 hours. The test can also be run simultaneously with other assays provided by Roche for use on the cobas 6800/8800 Systems. Roche will have millions of tests a month available for use on the cobas 6800 and 8800 systems, upon authorisation, according to today’s announcement.

Roche Chief Executive Officer Thomas Schinecker said in a statement:

“Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic…”. “Over the last weeks, our emergency response teams have been working hard to bring this test to the patients. CE-mark certification and the FDA’s granting of EUA supports our commitment to give more patients access to reliable diagnostics which are crucial to combat this serious disease.”

Roche’s test is the first-ever novel coronavirus commercially available test and the third coronavirus diagnostic tool to get emergency clearance from the FDA. The other two COVID-19 testing devices were developed by the U.S. Centers for Disease Control and Prevention and by the New York State Department of Health.

Sources:

Roche press release (March 13, 2020): Roche’s cobas SARS-CoV-2 Test to detect novel coronavirus receives FDA Emergency Use Authorization and is available in markets accepting the CE mark

FDA press release (March 13, 2020): Coronavirus (COVID-19) Update: FDA gives flexibility to New York State Department of Health, FDA issues Emergency Use Authorization diagnostic

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