Media Release

25.12.2020

Roche partners with Moderna to include SARS-CoV-2 antibody test in ongoing COVID-19 vaccine trials

  • Moderna’s vaccine triggers an antibody response to the SARS-CoV-2 spike protein
  • The antibody test to spike (S) protein of SARS-CoV-2 can quantitatively measure the level of antibodies against SARS-CoV-2 in vaccine trial participants and could help to establish correlation to protection from COVID-19
  • Emergency Use Authorisation by the US FDA for the Ab test was granted on 25 Nov, 2020
     

Basel, 9 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced a partnership with Moderna Inc. to utilise the antibody test to S protein of SARS-CoV-2 in Moderna’s mRNA-1273 vaccine research trials. This will facilitate the quantitative measurement of SARS-CoV-2 antibodies and help to establish a correlation between vaccine-induced protection and levels of anti-receptor binding domain (RBD) antibodies. Significantly, Moderna’s vaccine triggers antibody response specifically to the RBD of the SARS-CoV-2 spike protein. This follows the recent announcement that Roche has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the antibody test to S protein of SARS-CoV-2.

“Roche values the collaboration with Moderna, which has already included the successful use of our qualitative the antibody test to SARS-CoV-2 antibodies, targeting the nucleocapsid protein, in an earlier part of the studies”, said Thomas Schinecker, CEO Roche Diagnostics. “We are pleased to see that our quantitative test for antibody of 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.”

Measuring the quantitative levels of anti-RBD SARS-CoV-2 antibodies using Roche’s test will help Moderna to gain valuable insights into the correlation between protection from vaccination and antibody levels. This could play a role in assessing if, or when, an individual needs revaccination, or in helping to answer other clinically relevant questions.

To enhance our understanding of vaccines against SARS-CoV-2 there would be a benefit in knowing the starting levels of antibodies a person has, prior to vaccination, in order to evaluate any change in antibody levels that the vaccine induces. This is particularly relevant in the case of antibodies directed against the SARS-CoV-2 spike protein, since these antibodies have been shown to have potent antiviral activity and correlate to potential immunity.1 Measuring antibody levels can also play a role in establishing vaccine efficacy in the prevention of infection and/or the development of severe COVID-19.2

This partnership with Moderna, started by using the Anti-SARS-CoV-2 test for qualitative determination of anti-N SARS-CoV-2 antibodies. This has been part of Moderna’s vaccine trials for baselining and assessing natural infection in trial participants.

About the SARS-CoV-2 antibody test  

The SARS-CoV-2 antibody test can detect antibodies to the coronavirus, which could signal whether a person has been already infected and potentially developed immunity to the virus. This test can also help in the determination of seroprevalence (i.e. the frequency of individuals with antibody to the virus), in a given population, as well as a complement test to Nucleic Acid Amplification Tests (NAAT) for the diagnosis of SARS-CoV-2 infection.

About Roche’s response to the COVID-19 pandemic

As a leading healthcare company we are doing all we can to support countries in minimising the impact of COVID-19.  We have developed a growing number of diagnostic solutions that help to detect and diagnose the infection in patients, as well as providing digital support to healthcare systems, and we continue to identify, develop and support potential therapies which can play a role in treating the disease.

We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times. As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future.

Our diagnostics solutions:

Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. Our portfolio includes:

  • a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorisation (EUA) and available in countries accepting the CE Mark)
  • a SARS-CoV-2 laboratory-based antibody test, aimed at detecting the presence of antibodies in the blood targeting the nucleocapsid (FDA EUA and CE Mark)
  • an IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19  (FDA EUA and CE Mark)

 

 

References
[1] Masters PS (2006). The molecular biology of coronaviruses. Advances in Virus Research. Academic Press. 66: 193–292; (2) Hoffmann, Markus et al. (2020). Cell. 81(2):271-280.e8;
[2] Zhu FC et al. (2020). Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. The Lancet 396:479 - 4882)
[3] Full specifications of the Roche immunoassay systems, including throughput, can be found on our diagnostics.roche website