Summary
On March 12, 2020, Roche received FDA Emergency Use Authorisation 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.
On October 15, 2020, FDA authorised the use of pooled samples, containing up to and including 6 individual samples, for cobas® SARS-CoV-2 Test for use on the cobas® 6800/8800 Systems. This pooling workflow is not available in markets accepting the CE mark.
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 nasal, nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing.
On September 3, 2020, Roche received FDA Emergency Use Authorisation for the cobas® SARS-CoV-2 and Influenza A/B Test to to simultaneously detect and differentiate between viruses that cause COVID-19, Influenza A and Influenza B in patients suspected by their healthcare provider of having a respiratory viral infection consistent with COVID-19. The CE-IVD test is also available in markets accepting the CE mark.
cobas® SARS-CoV-2 and Influenza A/B assay for use on the cobas® 6800/8800 Systems (cobas® SARS-CoV-2 and Influenza A/B) is an automated multiplex real-time RT-PCR assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus RNA in healthcare provider-collected nasal and nasopharyngeal swab specimens, and self-collected nasal swab specimens (collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. The SARS-CoV-2 design is a dual target approach, which detects SARS-CoV-2-specific nucleic acid sequences in the ORF1a/b non-structural region, as well as in a conserved region from the E gene that is common to all Sarbecoviruses, including SARS-CoV-2. For influenza A and influenza B viruses, the multiplex assay targets the matrix proteins 1 and 2 (M1/M2) genes for influenza A and the nuclear export protein (NEP) / nonstructural protein 1 (NS1) genes for influenza B, respectively.
Where are these tests performed?
These tests are designed for use on the cobas® 5800 and cobas® 6800/8800 Systems, with a combined global install base of nearly 1000 instruments, in hospitals and reference laboratories.
Global list of all countries where systems are currently installed.
Where are the tests made?
The cobas® SARS-CoV-2 and cobas® SARS-CoV-2 and Influenza A/B Tests for use on the cobas® 6800/8800 Systems are produced in New Jersey, USA. The cobas® 6800/8800 Systems are made in Switzerland.
How fast are the tests?
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?
We continue to produce millions of tests each month across our portfolio. In response to the ongoing COVID-19 public health crisis, Roche is making substantial investments in building additional manufacturing capacity to increase production of tests and the instruments on which they are performed.
How are you deciding who gets the tests?
We are partnering with customers, nonprofits, governments and regulatory bodies to ensure that tests are supplied to 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. Both tests can only be ordered by a medical professional.
How can I contact a Roche representative regarding access to COVID-19 testing products?
Please contact us via our website contact form or Access our global affiliates page on www.roche.com
