Roche teams up with Moderna to add antibody test in COVID-19 vaccine trials
Roche revealed a new collaboration agreement with Moderna to use the Elecsys® Anti-SARS-CoV-2 S antibody assay in Moderna’s COVID-19 vaccine clinical studies. This agreement comes after the recent announcement that Roche’s Elecsys® Anti-SARS-CoV-2 S antibody test has been granted Emergency Use Authorization (EUA) by the U.S. FDA.
Using the Roche antibody test, Moderna will be able to obtain helpful data into the link between vaccination protection levels and the created antibody levels. This may contribute to identifying whether and when a person needs re-vaccination, or in helping to address other clinical questions.
Moderna’s vaccine, which has shown effectiveness of up to 94.5% in recent Phase 3 trials, triggers an antibody response specifically to the anti-receptor binding domain (RBD) of the SARS-CoV-2 spike protein this cooperation will enable the precise quantitative measurement of SARS-CoV-2 antibodies and help to establish a correlation between vaccine-induced protection and levels of RBD antibodies.
Determining antibody levels
To help researchers understand COVID-19 vaccines an important advantage would be knowing the starting levels of antibodies against SARS-CoV-2 a person has before vaccination in order to determine any improvement in antibody levels that the vaccine triggers. This is especially important for the antibodies generated as an immune response towards the SARS-CoV-2 spike protein as these antibodies have been shown to have strong antiviral activity and equate with potential immunity. Monitoring the antibodies titre can also play a role in determining the vaccine effectiveness in avoiding infection or developing extreme COVID-19.
Thomas Schinecker, CEO of Roche Diagnostics said:
“Roche values the collaboration with Moderna, which has already included the successful use of our qualitative Elecsys Anti-SARS-CoV-2 test, targeting the nucleocapsid protein, in an earlier part of the studies. We are pleased to see that our quantitative Elecsys SARS-CoV-2 S test, which targets the spike protein, is now also being used as part of the Moderna vaccine trials, which could ultimately help to end this pandemic.”
Roche’s partnership with Moderna has started by utilising the Elecsys Anti-SARS-CoV-2 test for qualitative evaluation of anti-N SARS-CoV-2 antibodies which has been part of Moderna’s mRNA-1273 vaccine studies evaluating the average natural infection developed in the study participants.
About Elecsys Anti-SARS-CoV-2 S test
Elecsys® Anti-SARS-CoV-2 S is an immunoassay for the quantitative, in vitro evaluation of SARS-CoV-2 antibodies in human serum and plasma. The test will determine the quantity of antibodies to the coronavirus spike protein by means of a blood sample. The test specifically targets antibodies directed towards the particular area of the viral spike protein responsible for binding to the receptor of the host cell enabling the virus to enter the host cell.
The presence and level of such antibodies could indicate that a person has already been infected and has, potentially, generated immunity to the virus. This plays an important role in determining a vaccine-induced immune response. Many of the existing vaccine nominees are targeted to trigger an antibody response to the spike protein, such as Moderna’s mRNA-1237 COVID-19 vaccine candidate.
About Elecsys Anti-SARS-CoV-2 test
Elecsys Anti-SARS-CoV-2 is an immunoassay for the qualitative in vitro identification (including IgG) of SARS-CoV-2 antibodies. The test will detect antibodies to the coronavirus that may suggest whether a person has already been infected and that immunity to the virus has been potentially created. This test can also be used to determine seroprevalence (i.e. the rate of individuals with antibodies to the virus ) in a certain population, as well as to complement the Nucleic Acid Amplification Test (NAAT) tests for the diagnosis of SARS-CoV-2 infection.
Both tests run on Roche’s cobas e analyzers which are widely available around the world and can be carried out by hospitals and laboratories. SARS-CoV-2 test results can be provided by these fully automated systems in approximately 18 minutes, with a test throughput of up to 300 tests per hour, depending on the analyzer.
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