Roche Receives FDA EUA for New Test Measuring Level of COVID-19 Antibodies

LabCorp, an early adopter with extensive geographic reach, will be the first lab offering the test in the United States.

Roche, one of the world’s largest biotech companies, has been approved by the FDA for an Emergency Use Authorization on it’s SARS-CoV-2 antibody test. The test, named Elecsys®, is a semi-quantitative blood test and can measure the level of antibodies in those who have had an exposure to the coronavirus disease 2019 (COVID-19). 

Elecsys® is able to specifically detect antibodies against the virus’s area known as the spike protein. This area enables the virus cell to bind to its hosts cell receptor, which allows the virus to enter the host cell. As well as the qualitative results given by the test, it also provides a numerical result from 0.40-250 U/mL.

The test serves two purposes that will help in the fight against COVID-19. First, due to the fact that candidate vaccines aim to induce an antibody response, the test will be able to measure the level of immune response someone has over time. Second, the semi-quantitative test can help to lead the way on how plasma donations are allocated for convalescent plasma therapy.

"Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against COVID-19," Matt Sause, president and CEO of Roche Diagnostics Corporation said. "Antibody tests like these will play a critical role in measuring a person's vaccine-induced immune response and supporting the development of convalescent plasma therapy to help other patients fight the disease."

The laboratory-based test will run on Roche’s cobas e analyzers, which are already widely available. The introduction of Elecsys® adds to the companies growing list of diagnostic tools, which includes serology and digital solutions, that aid healthcare workers during the current pandemic. Roche will start shipping the test to laboratories within the next week.

"As vaccines and other therapeutic treatments become available, it will become more important to have tests which are more specific about the levels of antibodies in patients," Brian Caveney, chief medical officer and president of LabCorp Diagnostics said. "We're pleased to expand our offerings in the fight against COVID-19 and be the first national lab to offer Roche's semi-quantitative test to the market."