Roche plans to ship an additional 400,000 tests per week to the laboratory testing sites across the nation that are set up to run the test immediately under the guidelines of the U.S. Food and Drug Administration Emergency Use Authorization.
“We are grateful to the FDA for accelerating the process to grant Emergency Use Authorization for this test,” said Matt Sause, president and CEO of Roche Diagnostics North America. ”
We began shipping test kits immediately so labs could start to offer high-volume testing as soon as possible and give more patients access to reliable diagnostics.
Together, we can help combat this serious disease.” Under the EUA, the cobas SARS-CoV-2 Test is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in patients who meet COVID-19 clinical and/or epidemiological criteria for testing.
The test uses nasopharyngeal or oropharyngeal swab samples taken from the back of the nose or throat. The test kits are being sent to a network of more than 30 hospital and reference laboratories in the U.S. that already have the required instrumentation in place and have the ability to implement high-volume testing immediately.
Roche consulted with government agencies to ensure that the test distribution prioritizes labs with the broadest geographic reach and highest patient impact.
Healthcare providers across the entire U.S. can send patient samples to these laboratories for processing.