Roche received a green light from the FDA for emergency use of its high-volume coronavirus diagnostic, the first commercially developed test to do so. The agency said it approved the test within 24 hours of receiving the application.
The fully automated test is expected to substantially boost testing capacity in the U.S. in the coming days. Previously, the FDA authorized preapproved but validated testing for the novel coronavirus at specific, certified “high complexity” laboratories.
Now, this latest Emergency Use Authorization enables clinicians to run the Roche test on the company’s cobas 6800/8800 molecular testing systems, widely available at hospitals and labs throughout the country. It is also available in European countries accepting the CE mark.
In addition to the one-day approval, the FDA said it did not object to Roche pre-shipping its COVID-19 tests to laboratories ahead of time, so they could be used immediately following the authorization.
“We have been encouraging test developers to come to the FDA and work with us,” said the agency’s device and diagnostic center director, Jeff Shuren.
“Since the beginning of this outbreak, more than 60 developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process,” Shuren added. “Additionally, more than 30 laboratories have notified us they are testing or intend to begin testing soon under our new policy for laboratory developed tests for this emergency.”
Previously, the FDA granted emergency authorizations to diagnostic panels developed by the CDC and the New York State Department of Health. The agency also granted the state health department the authority to allow certain labs to proceed with testing without any federal approval or regulatory submissions. Those labs would instead interact solely with New York State health officials.
In a series of tweets, former FDA Commissioner Scott Gottlieb described Roche approval as a significant milestone that could increase the number of COVID-19 tests performed in the country by tens of thousands per day. Gottlieb added that, with more testing, it is likely to uncover a wider spread of the disease than is currently known.
As of March 13, the U.S. has seen at least 1,700 confirmed cases, with 40 deaths from the disease. According to the Centers for Disease Control and Prevention’s (CDC's) last count, a total of 13,624 tests have been performed since late January at the CDC and other public health laboratories.
The test is designed to detect nucleic acid strands of the SARS-CoV-2 virus from nasal or oral swabs. However, the company said negative results do not preclude an infection and should be combined with clinical observations and the patient’s history and contact with the disease.
The cobas test aims to provide results in three-and-a-half hours, with a total of 1,440 samples tested per day on the 6800 system and 4,128 per day on the larger 8800. It can also be run simultaneously with other disease assays.
“Roche is committed to delivering as many tests as possible and is going to the limits of our production capacity,” the company said in a statement, and it expects to have millions of tests available per month.