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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 Elecsys® Anti-SARS-CoV-2 S test can semi-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 Authorization by the US FDA for the Elecsys Anti-SARS-CoV-2 S test was granted on November 25, 2020

 

INDIANAPOLIS, December 9, 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced a partnership with Moderna Inc. to utilize the Elecsys® Anti-SARS-CoV-2 S antibody test in Moderna’s mRNA-1273 vaccine research trials. This will facilitate the semi-quantitative measurement of SARS- CoV-2 antibodies and help to establish a correlation between vaccine-induced protection and levels of anti-spike receptor binding domain (RBD) antibodies. 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 Elecsys® Anti-SARS-CoV-2 S antibody test.

 

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 (N) protein, in an earlier part of the studies, said Thomas Schinecker, CEO Roche Diagnostics. We are pleased to see that our semi- 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.

 

Measuring the 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.1 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 Elecsys Anti-SARS-CoV-2 test for qualitative determination of nucleocapsid SARS-CoV-2 antibodies. This has been part of Moderna’s vaccine trials for baselining and assessing natural infection in trial participants.

 

About potential SARS-COV-2 vaccines

 

Candidate vaccines, such as Moderna’s mRNA-1237, aim to induce an antibody response against the SARS-CoV-2 spike protein. Any potential vaccine for SARS-CoV-2 would work (amongst other mechanisms) by triggering the immune response to develop neutralizing antibodies in the person receiving the vaccine. In doing so, the vaccine trains the body’s immune system to recognize and fight an exposure to SARS-CoV-2, in a controlled way, without being exposed to the intact virus.2

 

About Elecsys Anti-SARS-CoV-2 S test

 

 

Elecsys® Anti-SARS-CoV-2 S is an immunoassay for the qualitative and semi-quantitative, in vitro determination of antibodies to SARS-CoV-2 in human serum and plasma. Through a blood sample, the test can measure the quantity of antibodies to the spike protein of the coronavirus. Specifically, the test targets antibodies which are directed against the particular region of the viral spike protein responsible for binding to the host cell receptor, which is required for the virus to enter the host cell.

The presence and level of such antibodies could signal whether a person has been already infected and potentially developed immunity to the virus.

This plays an important part in characterizing a vaccine-induced immune response.2 The majority of current candidate vaccines aim to induce an antibody response against the spike protein.

 

About Elecsys Anti-SARS-CoV-2 test


Elecsys Anti-SARS-CoV-2 is an immunoassay for the qualitative, in vitro detection of antibodies to SARS-CoV-2 in human serum and plasma. The test can detect antibodies to the coronavirus, which could signal whether a person has already been 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.

Clinical laboratories can run both of these tests on Roche’s cobas e analyzers which are widely available around the world. These fully-automated systems can provide SARS-CoV-2 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyzer.3

 

About Roche’s response to the COVID-19 pandemic


To address the global COVID-19 healthcare crisis, Roche has developed a growing number of diagnostic solutions that help detect and diagnose the infection in patients, as well as providing digital support to healthcare systems. Roche also continues to identify, develop and support potential therapies that can play a role in treating the disease. Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic.

Roche continues to work with healthcare providers, laboratories, authorities and organizations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times.

The Roche portfolio of COVID-19 solutions includes:

  • a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, (FDA Emergency Use Authorization (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)
  • a high-volume molecular test to simultaneously detect and differentiate between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both (FDA EUA and CE Mark)
  • a second SARS-CoV-2 antibody test, aimed at measuring antibody response to the spike protein, to help assess a patient’s immune response and support the development of convalescent plasma therapy (FDA EUA and CE mark)
  • a point-of-care molecular PCR test that simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B infections to support urgent triage and diagnosis (FDA EUA and CE Mark)

 

About Roche

 

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognized as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

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

For Further Information

Roche Diagnostics US Media Relations
 
Michael Weist

1-317-371-0035
mike.weist@roche.com
us.mediarelations@roche.com