Updated March 30, 2020
Summary
On March 12, 2020, Roche received FDA Emergency Use Authorization for the cobas® SARS-CoV-2 Test to detect the virus that causes COVID-19, which the World Health Organization has classified as a pandemic. 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.
How does the test work?
The test detects the genetic signature (RNA) of the SARS-CoV-2 virus in swab samples that a healthcare provider collects from the back of the patient’s throat or nose.
Where is the test performed?
Healthcare providers can send patient samples to hospital and reference laboratories across the U.S. to run the test. As of March 27, 2020 there are currently over 60 laboratory sites serving all 50 states and Puerto Rico.
Where is the test made?
Roche designed the test in California and produces it in New Jersey. The cobas 6800/8800 Systems are manufactured in Switzerland.
How fast is the test?
After the lab starts the test, results are available in about 3.5 hours. The instruments can process up to 384 results (cobas 6800 System) and 1056 results (cobas 8800 System) in an 8-hour shift.
How many tests can you supply?
Roche began shipping tests to U.S. laboratories on March 13. We expect to supply 400,000 tests per week to the U.S. market.
What is the price of the test?
Although our EUA test was the first new commercial test introduced during this unprecedented pandemic, its price remains consistent with all other standard viral tests for use on the cobas® 6800/8800 Systems platform.
Individual labs determine the price of the tests they offer to patients.
Will there be enough tests to meet demand?
We are doing everything possible to produce as many tests as we can. Since this is a global health emergency, demand is outpacing supply.
Roche welcomes the subsequent Emergency Use Authorization (EUA) of more than 15 additional tests developed by our competitors, spanning various platforms and features, which together will help to meet demand.
How is Roche deciding what customers get the test?
We are working to ensure the greatest access for patients in the U.S. – and the rest of the world - by bringing together the nation’s public-health interests with the development and testing capacities of the private sector. In close consultation with the government we are supporting the national public health strategy by prioritizing access to:
Large commercial laboratories—with the necessary instruments in place—that can quickly collect, process and move samples to maximize testing capabilities and provide the widest geographic coverage.
Hospitals and laboratories in geographic regions that are currently experiencing large-scale community spread of infection.
The situation is fluid and we are adapting our strategy in real time. We monitor daily customer inventory levels and test usage. This information helps us update our allocation planning as necessary to ensure that we provide testing supplies where and when they are needed most.
Do you foresee any disruption to the test supply as a result of closed borders?
Given the importance of these tests, we have been able to work with the authorities to ensure continuity of supply and we do not anticipate closed borders being an obstacle.
Will travel restrictions impact the ability to service hospitals / instruments running the SARS-CoV-2 test?
Our focus remains to keep customers up and running. We have a task force that meets daily to ensure rapid response to emerging crisis topics that may impact support. Our current strategies that are intended to keep our employees safe, optimize our service and keep our customers in operation include:
Providing credentials and documentation to service personnel to ensure emergency travel capabilities to customer sites.
Remote, home-based set up for all personnel not required on customer sites, including the Customer Support Center.
Increased stock of spare parts located regionally, including supply at alternate warehouses, including those specific to the cobas 6800/ 8800 analyzers that run the SARS-CoV-2 test.
Dedicated toll-free line for customers who are allocated SARS-CoV-2 testing for related parts ordering. This ensures a more streamlined experience for both customers running COVID-19 related testing and those who need support for routine testing.
Where can patients get the test?
Roche does not supply tests directly to patients. If you think you have been exposed to COVID-19 and develop a fever and symptoms, such as cough or difficulty breathing, call your healthcare provider for medical advice. The test can only be ordered by a medical professional and is intended for patients who meet the clinical and epidemiological criteria for COVID-19 testing.
Is Roche going to launch other diagnostic solutions in support of this current pandemic?
Roche is deeply committed to supporting the global response to the COVID-19 outbreak. We will continue to bring all of our organizational expertise and resources to this battle. Given Roche’s broad suite of diagnostic solutions, we have numerous options between high-volume, centralized testing to rapid, decentralized testing. We’ll continue to evaluate the epidemiology of the disease and public health needs to help us determine how to best support this healthcare crisis. We remain open to all platform development options.
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