Roche Holding AG has revealed a partnership with Moderna Inc. involving the use of the Elecsys Anti-SARS-CoV-2 S antibody test in the latter’s mRNA-1273 vaccine research trials. The news comes shortly after Roche received emergency use authorization (EUA) from the U.S. FDA for the 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 protein, in an earlier part of the studies,” said Thomas Schinecker, CEO of Roche Diagnostics. “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.”
The test is an immunoassay for the quantitative, in vitro determination of antibodies to SARS-CoV-2 in human serum and plasma. Specifically, it targets antibodies that are directed against the 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. It is for use on the cobas e analyzers and aims to help identify individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection.
Measuring the quantitative levels of antibodies using Roche’s test aims to help Moderna to assess the correlation between protection from vaccination and antibody levels. It could help show whether someone needs revaccination and potentially answer other clinically relevant questions.
Researchers have shown that there is 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. Measuring antibody levels also can play a role in establishing vaccine efficacy in the prevention of infection and/or the development of severe COVID-19.
This partnership with Cambridge, Mass.-based Moderna, started by using the Elecsys Anti-SARS-CoV-2 test for qualitative determination of anti-N SARS-CoV-2 antibodies. That immunoassay is for the in vitro detection of antibodies, including IgG, to SARS-CoV-2.
Moderna is far along with its candidate, filing for an EUA with the U.S. FDA. An agency advisory meeting is set for Dec. 17. Data confirmed the vaccine to be 94.1% effective in preventing symptomatic cases of the disease and 100% effective in preventing severe cases. As of Oct. 22, 30,000 participants had been enrolled in the COVE phase 3 study.
The partnership will run for the duration of the vaccine trials in instances in which quantitative measurement of antibodies against the spike protein is required, Roche said, adding that it is open to partnering with other manufacturers if the opportunity presents itself.
During Basel, Switzerland-based Roche’s Oct. 15 third-quarter earnings call, Schinecker noted that the company launched its first antibody assay in May. He also highlighted that its quant antibody assay had been used in vaccine trials.
Schinecker said that his group experienced 18% growth, as its core business started to come back. “Although it's not back 100% to normal, it has come back significantly,” he said, adding that the uptake of COVID-19 tests propelled the business forward. The molecular diagnostics line alone saw 77% growth.
Simon Baker, with Redburn Ltd., asked for an update related to the uptake of the COVID antibody test. Schinecker said there was demand for the test launched in May of about 10 million a month. “And this is pretty constant over the last couple of months.” He also touched on the quant spike antibody assay as being key in terms of vaccine development. “Now we believe that once vaccines will come to the market, antibody testing will become definitely a lot more relevant going forward.”