Roche Developing High-Volume COVID-19 Antigen Testing Product

October 19, 2020 - Roche recently announced that it will launch a new high-volume COVID-19 antigen test, which will be made available at the end of 2020 for markets accepting the CE Mark.

The Elecsys SARS-CoV-2 Antigen test will run on all Roche cobas e immunochemistry analyzers, which are available globally. This will help to boost testing capacity, the company stated. 

Healthcare professionals will use nasopharyngeal or oropharyngeal swab samples from patients with coronavirus symptoms or individuals with known exposure to the virus. 

The test results will be available in 18 minutes after a single test, with a throughput of up to 300 tests per hour from a single analyzer, Roche said, but this is dependent on the analyzer itself. 

“We are aware that governments and healthcare systems are under intense pressure to increase SARS-CoV-2 testing capacity to effectively manage the spread of the virus. A high-volume antigen test is a valuable addition to the testing portfolio for helping diagnose SARS-CoV-2 infection,” Thomas Schinecker, CEO of Roche, said in the announcement. 

“Being able to quickly and correctly identify if someone has a SARS-CoV-2 infection is critical to informing patient management decisions and containing the spread of COVID-19. Roche remains committed to supporting governments, healthcare professionals and patients to fight this pandemic with the help of our diagnostics solutions.”

This laboratory-based antigen test will allow for cost error reduction due to the removal of manual handling, as well as quicker turn-around times and high test throughput, the company noted.

Both antibody drugs and tests are vital during the pandemic to provide valuable public health information by uncovering if an individual’s immune system has developed the antibodies needed to fight off the virus.  

Elecsys is another addition to the comprehensive Roche diagnostic profile of potential COVID-19 treatments. 

In April, Roche announced the development of an anti-SARS-CoV-2 serology test to detect antibodies in individuals who have been exposed to COVID-19.

The test was designed to identify individuals who have been infected by the virus, especially those who do not display any symptoms. 

Additionally, the test was also used to screen high-risk groups, including healthcare workers and food supply workers, who may have developed immunity and can safely return to work. 

The immunoassay is an in vitro test that uses human serum and plasma drawn from a blood sample to detect antibodies and determine the body’s immune reaction to SARS-CoV-2.

But because Roche’s serology test was one of the first of this kind to launch in the US, some roadblocks prevented it from complete success. 

Just a month after the company introduced Elecsys, 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 serological COVID-19 antibody testing.

Specifically, FDA did not review any COVID-19 antibody test kits before they went to market, therefore they cannot validate the accuracy of the ones that had already been launched. 

The new and improved Elecsys, which will support a higher-volume of testing, may prove more successful than the April launch. 

Additionally, Roche intends to file for emergency use authorization from the FDA. 

“We understand the impact of COVID-19 goes beyond those who contract it, which is why we are working with healthcare providers, laboratories, authorities and organisations to help make sure that patients continue to receive the tests, treatment and care they need during these challenging times,” Roche stated.

“As we learn from the pandemic, we are partnering with governments and others to make healthcare stronger and more sustainable in the future.”