Roche Receives FDA Approval for COVID-19 Antibody Test

December 04, 2020 - Roche recently announced that its COVID-19 antibody test, Elecsys, received FDA emergency use authorization.

Elecsys Anti-SARS-CoV-2 S measures the level of antibodies to the spike protein of COVID-19, which can uncover whether an individual has already been infected and has developed immunity to the virus.

“Since the start of this pandemic, our focus has been to bring effective diagnostic testing solutions to the fight against COVID-19,” Thomas Schinecker, CEO of Roche, said in the announcement. “Antibody tests like these will play a critical role in measuring a person’s vaccine-induced immune response.” 

At the end of April, Roche announced the development of its Anti-SARS-CoV-2 test. The test was initially designed to identify individuals who have been infected by the virus, especially those who do not display any symptoms.

The main objective was to screen high-risk groups including healthcare workers and food supply workers who may have developed immunity so they could safely return to work. 

But just weeks later, the Subcommittee on Economic and Consumer Policy released a staff memo with preliminary findings that showed significant gaps in the Trump Administration’s handling of antibody COVID-19 tests.  

A few main concerns included that FDA did not review any COVID-19 antibody test kits before they went to market and, therefore, could not validate their accuracy.  

Therefore, in September, Roche released the improved Elecsys Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. 

The new test can only be administered after determining the level of antibodies a person already had. This ensured experts could track any changes in antibody levels that the vaccine induces, Roche said in the September announcement. 

In addition to measuring a patient’s immune response, the test may also help to guide the distribution of plasma donations from recovered coronavirus patients. 

Researchers would do this through plasmapheresis, a procedure which separates and removes the plasma from a patient’s blood. This plasma is then replaced with plasma from a donor, Roche said. 

Using the Elecsys Anti-SARS-CoV-2 S antibody test, together with Roche’s Elecsys Anti-SARS-CoV-2 test launched in May, can help to more accurately determine the percentage of a population who already have antibodies against SARS-COV-2. 

Together, the tests can also help experts contain the spread and implement necessary restrictions, Roche said. 

Elecsys Anti-SARS-CoV-2 S is the latest addition to the company’s growing diagnostic profile. 

Antibody tests can provide valuable public health information to uncover if an individual’s immune system has developed the antibodies needed to fight off infections, particularly COVID-19. 

During the pandemic, top pharmaceutical companies, including Siemens Healthineers, have also launched a COVID-19 antibody test. 

At the end of November, Siemens Healthineers announced the launch of its SARS-CoV-2 IgG Antibody Test (COV2G), which has previously proven to measure neutralizing antibodies and has achieved CE Mark. 

Notably, the test is an enhanced version of the company’s assay, which became available globally this summer. The company stated that it recently submitted an emergency use authorization for the new and improved test to FDA. 

“The ability to detect neutralizing antibodies can help us gain additional insight into what the existence of antibodies may mean for patients as we continue the fight against COVID-19,” Tim Stenzel, MD, PhD, Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a November press release.

“There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus,” Stenzel continued.