In mid-March, Roche began shipments of the first 400,000 Covid-19 tests to laboratories across the United States to begin patient testing under the US Food and Drug Administration (FDA) Emergency Use Authorization, according to the company. The first available commercial test kit for novel coronavirus will enable labs to expand and expedite testing to meet urgent medical needs. A broad network of labs will use Roche's automated cobas SARS-CoV-2 Test to process high volume of patient samples sent from across the US.

"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, in a news release. "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 Emergency Use Authorization, 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 US 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 US can send patient samples to these laboratories for processing.

The labs run the test on Roche's fully automated cobas 6800 and cobas 8800 Systems, which can process up to 384 results (cobas 6800 System) and 1056 results (cobas 8800 System) in an eight-hour shift. After the lab starts the test, results are available in about three-and-a-half hours. The test can only be ordered by a medical professional, so patients who have symptoms consistent with Covid-19 should go to their healthcare provider for evaluation.

Roche's global headquarters for Roche Molecular Solutions, which includes Molecular Diagnostics Sequencing Solutions and Tissue Diagnostics, is located at Hacienda. Molecular Diagnostics develops and manufactures innovative laboratory diagnostic tests based on Nobel Prize-winning polymerase chain reaction technology. This technology underlies diagnostic tests that allow healthcare providers to select treatment and monitor patient response to therapy or can identify molecular characteristics of a disease.

For more information about Roche, please visit www.roche.com.

For more information about the cobas SARS-CoV-2 Test, please visit www.diagnostics.roche.com.

For technical information about the test is available at cobas SARS-CoV-2 Test, please visit www.diagnostics.roche.com/global/en/products/params/cobas-sars-cov-2-test.html.