Roche to Launch Self-Administered COVID-19 Antigen Test

February 09, 2021 - Roche recently announced that it received the CE mark for its new self-administered COVID-19 antigen test, which will be available in countries accepting the CE mark by the middle of this month. 

In comparison to Roche’s existing SARS-CoV-2 rapid antigen test, Elecsys Anti-SARS-CoV-2 S, the new SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx. 

This testing method is faster and less invasive, which helps to reduce patient discomfort, especially in sensitive individuals including children, the elderly, and individuals with disabilities. 

“Rapid testing continues to play an important role in the fight against COVID-19, especially in places when laboratory testing is not available and quick results are needed, such as nursing homes, healthcare facilities, and schools.” Thomas Schinecker, CEO of Roche Diagnostics said in the announcement. 

“The SARS-CoV-2 Rapid Antigen Test Nasal provides patients with a more comfortable testing experience,” Schinecker continued. 

The SARS-CoV-2 Rapid Antigen Test Nasal provides patients with the option to self-collect their nasal sample under the supervision of a healthcare provider, which can help to reduce exposure to the coronavirus for both patients and providers.  

Future regulatory requirements will inform if the test can be administered without supervision. 

Roche partnered with SD Biosensor for the launch of the test. Previously, Roche tapped SD Biosensor to launch two of its SARS-CoV-2 Rapid Antibody Tests. 

At the end of April, Roche developed its first Anti-SARS-CoV-2 serology test, Elecsys. 

The test aimed to identify individuals who have been infected by COVID-19, especially those who do not display symptoms. The test also screens high-risk groups so they can return to work safely. 

But 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 could not validate the accuracy of the ones that had already been launched. 

So, at the end of September, Roche launched a new and improved Elecsys test for markets accepting the CE Mark.

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

Specifically, the test will measure the number of antibodies to the spike protein of COVID-19, which could uncover whether a person has been already infected and has potentially developed immunity to the virus.

But the enhanced Elecsys can only be administered after determining the level of antibodies an individual already has, which will help experts uncover any change in antibody levels that the vaccine induces, especially against SARS-CoV-2 spike protein.

FDA granted emergency use authorization for Elecsys at the beginning of December. 

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 Abbott, have also launched COVID-19 antibody tests. 

September data submitted to FDA found that Abbott’s BinaxNOW COVID-19 Ag Card Home Test showed a sensitivity of 97.1 percent and specificity of 98.5 percent in patients suspected of having coronavirus by their healthcare provider.

Due to these positive results, FDA issued an emergency use authorization for Abbott’s test at the end of December. It is authorized for use by patients with prescription.

The test is authorized for use in individuals 15 years of age or older who are suspected of having COVID-19 by their healthcare provider and who are within the first seven days of symptom onset.