Authorization of Test by Indy Based Roche Diagnostics’ Significantly Contributes to Worldwide Battle Against Coronavirus

Writer // Janelle Morrison

Roche Diagnostics’ cobas® SARS-CoV-2 Test designed to detect the novel coronavirus received emergency use authorization by the U.S. Food and Drug Administration (FDA) on March 13, 2020. According to Roche Diagnostics the 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. Hospitals and reference laboratories can run the test on Roche’s fully automated cobas® 6800 and cobas® 8800 Systems, which are widely available in the U.S. and around the world.”

Gary Geipel, senior director of corporate communications at Roche Diagnostics—U.S. headquarters, shared, “This test is specific to the current novel coronavirus that is out there now. The official name begins with SARS because this [COVID-19] is a variant of the previous virus that people called the SARS virus.”

What does this news mean for the detection efforts locally, nationally, and globally?

  • First commercial test for SARS-CoV-2 will enable expedited coronavirus testing to meet urgent medical needs
  • Testing on widely available, high-volume cobas 6800/8800 will significantly increase available testing capacity
  • Roche expedites test development to support urgent need for patient testing during pandemic outbreak to avoid a further spread of the virus at an early stage of infection

The CE-IVD test is also available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 disease and living in affected areas where the SARS-CoV-2 virus is known to be present.

Why Did the FDA Grant Emergency Use Authorization to Roche?

It is generally understood that there is a need for as many as tests as possible within the United States. When asked what motivated the FDA to grant Roche the ability to mobilize its cobas SARS-CoV-2 Test to and begin immediately shipping to labs and hospitals across the nation, Geipel replied, “The need for as many tests as possible [in the U.S.] was one motivation the FDA clearly had to increase the number of tests available. The Roche test can be conducted in a highly automated manner. It works on a testing system that Roche has been selling since 2016 and is a platform that is widely available in the U.S.”

Geipel continued, “This test kit can be used on systems that are up and running and are geographically dispersed which is another reason why this made it very attractive [to the FDA]. It is a high volume, fully automated test so there is no human intervention that could interfere with the results. It is able to be conducted on platforms that are available across the country and it significantly increases the number of tests that are available right now in the U.S. So, I think those are the reasons that caused the urgency for the FDA to act on this.”

How Fast Can Roche’s cobas SARS-CoV-2 Test provide results?

“There are two different variations of the Roche platforms,” Geipel explained. “One that is a little faster than the other, so depending on which platform is used in an 8-hour shift—for example—the systems can do between 800 and 1800 tests in that 8-hour shift. That would be at maximum capacity. The labs are the ones conducting these tests but that is a theoretical maximum capacity of these systems.”

The widely available Roche’s cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2 Test, provide test results in three and half hours and offer improved operating efficiency, flexibility, and 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 be run simultaneously with other assays provided by Roche for use on the cobas 6800/8800 Systems.

“As far as our test is concerned, we are in the process of starting to ship our first lot or batch of these tests,” Geipel said. “And for the United States, it will be between 400 and 500,000 tests [shipped] by next week. Those are being shipped out to be available next week and we expect that pace to continue. So, if you do the math that’s well over a million a month on the order if we continue at that pace, as we expect to do. We see that as an important contribution to fulfilling the need for tests in the United States right now.”

Who currently has this test or will have it within the next few days and weeks?

Geipel explained that the cobas® SARS-CoV-2 Test is being shipped to two different kinds of laboratories within the U.S.

“The test is being made available and being shipped as we speak,” Geipel said. “And starting Monday and Tuesday, it will be in the labs and able to be used. Basically, there are two types of laboratories. The first are the large national ‘reference’ laboratories as they are called. You’ve heard the president [Trump], vice-president [Pence] and others, name some of the laboratories by name. Lab Corp and Quest [Diagnostics] are two examples of these large national reference laboratories. The test is also being made available to some major hospital laboratories.”

How are the Tests Being Allocated and Where are they Manufactured?

Geipel explained how Roche is allocating its cobas® SARS-CoV-2 Test and if the areas identified as “Hot Spots” are the highest priorities.

“We are allocating the test in consultation with the CDC [Centers for Disease Control and Prevention] to make sure they agree with our philosophy,” Geipel stated. “And we are allocating the test based on the geographic reach of the laboratories and their proximities to the patients who are in the greatest need at the moment.”

Geipel was pleased to share that the cobas® SARS-CoV-2 Test is manufactured here in the U.S.

“They’re being manufactured in New Jersey,” Geipel stated. “And Roche Diagnostics in North America is headquartered here in Indianapolis. We are distributing these tests from here in Indianapolis so we’re certainly playing a role. My commercial colleagues have been intensively working with the laboratories to let them know what’s coming and how these tests work and all of that. So, it’s been a great Hoosier effort here and our contribution in getting these tests out there has been significant. We are very proud of that.”

For more information about the tests and system, please visit www.diagnostics.roche.com