On March 12, 2020, Roche received FDA Emergency Use Authorization and CE Mark for the cobas® SARS-CoV-2 Test to detect the virus that causes COVID-19, which the WHO has classified as a pandemic. 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.
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 cobas® SARS-CoV-2 Test is a single-well dual target assay, which includes both specific detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus family that includes SARS-CoV-2. The test detects the genetic signature (RNA) of the SARS-CoV-2 virus in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing.
Where is the test performed?
Healthcare providers can send patient samples to hospitals or reference laboratories capable of running the test on our systems. Our global install base for the cobas® 6800 and cobas® 8800 Systems is 695 and 132 respectively.
Global list of all countries where systems are currently installed
Where is the test made?
Roche designed the cobas® SARS-COV-2 Test in California and produces it in New Jersey. The cobas® 6800/8800 Systems are made in Switzerland.
How fast is the test?
After the lab starts the test, results are available in about 3 hours. The instruments can process up to 384 results (cobas® 6800 System) and 1,056 results (cobas® 8800 System) in an 8-hour shift.
How many tests can you supply?
Roche began shipping tests to U.S. laboratories immediately. We expect to supply about 400,000 tests per week or 1.5 million tests per month to the U.S. and more than 3 million globally for these systems
How is Roche deciding who gets the tests?
We want to make tests available to patients where they are needed most. So we worked with partners to develop a strategy that prioritizes labs with the broadest geographic reach and highest patient impact. These labs also have the ability to implement high-volume testing immediately.
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.
Where can patients get the test?
Anyone who has symptoms consistent with COVID-19 should go to a medical professional for evaluation. 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.
How long does it take to install a cobas® 6800 System or cobas® 8800 System in a hospital laboratory?
Under normal circumstances it takes about 1 week to install a new system in a laboratory that is properly prepared. This preparation involves ensuring adequate electric supply, assessment of environment for optimal performance, and careful planning for minimal disruption to laboratory operations. Please expect significant delays with new system installation due to unprecedented demand.
Does Roche supply bulk raw materials for lab developed tests?
Yes, please contact our CustomBiotech division for more details: https://custombiotech.roche.com/
How can I contact a Roche representative regarding access to COVID-19 testing products?