Roche Diagnostics in Indianapolis has begun shipping its test kits for the virus that causes COVID-19. The company says the delivery of the initial 400,000 test kits will be completed this week to laboratory testing sites throughout the country with many more on the way.
Roche says its cobas SARS-CoV-2 Test for COVID-19 uses swab samples taken from the back of the nose or throat and can provide results in about three-and-a-half hours. The U.S. Food and Drug Administration last week granted Roche Diagnostics an Emergency Use Authorization for the test.
“We are grateful to the FDA for accelerating the process to grant Emergency Use Authorization for this test,” Matt Sause, chief executive officer of Roche Diagnostics North America, said 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.”
Roche says it plans to ship an additional 400,000 test kits per week to sites across the U.S. The kits are being sent to a network of more than 30 hospital and reference labs that “already have the required instrumentation in place and have the ability to implement high-volume testing immediately.”
The company adds the test can only be ordered by a medical professional, so individuals with symptoms consistent with COVID-19 are being encouraged to contact their healthcare provider for evaluation. Roche says it consulted with government agencies to ensure labs with the broadest geographic reach and highest patient impact received priority distribution.
Roche Senior Vice President of Communications Randy Pritchard told our partners at WISH-TV last week the company began developing the test kits in January.