The distribution of COVID-19 vaccines has focused testmakers on how they can continue to contribute when vaccines are released. For Roche Diagnostics, vaccines and tests and their alignment are key to 2021 growth. Roche held its session “Entitled COVID-19: The critical role of Diagnostics,” on the first day of The American Association of Clinical Chemistry, Monday December 14th. The briefing focused on lessons learned from the global healthcare crisis, including challenges, solutions and future outlook. Thomas Schinecker, CEO Roche Diagnostics Division, Matt Sause, President and CEO of Roche Diagnostics North America, and William Morice, MD, PhD, President, Mayo Clinic Laboratories, a customer of Roche, participated in the discussion.
“Testing together with vaccines is key to stopping the pandemic,” Sause said.
Roche recently announced that its Elecsys® Anti-SARS-CoV-2 S antibody test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The semi-quantitative serology (blood) test can be used to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus. The new test targets antibodies that are directed against the region of the COVID-19 spike protein, specifically the area that enables the virus cell to bind to the host cell receptor, which is required for the virus to enter the host cell.
The test provides a numerical result from 0.40-250 U/mL reflecting the concentration of antibodies, as well as a qualitative result.
“Not all patients react the same way,” said Schinecker at the briefing. “What you can do with antbody tests is find out who has antibodies and to what level, and to test the effectiveness of a vaccine after they are vaccinated.”
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 actual virus. The company says 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.
Roche is partnering with Moderna to include a Covid-19 antibody test in the company’s ongoing vaccine trials for baselining and assessing natural infection in trial participants.
In other news, Roche confirmed it would apply for an EUA for its rapid POC antigen test, now in trials, in the early part of 2021. They also emphasized other areas, such as their transplantation test products, and cardiac markers.