Less Intrusive SARS-CoV-2 Rapid Antigen Test Nasal Announced

Basel-based Roche announced on February 1, 2021, it has obtained the CE mark for its new SARS-CoV-2 Rapid Antigen Test Nasal, which will become available by mid-February 2021.

Compared to the existing Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified and faster testing procedure. Whether the test could also be used without a healthcare professional's supervision will depend on local regulatory requirements.

“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,” said Thomas Schinecker, CEO Roche Diagnostics, in a press statement.

The launch is a partnership with SD Biosensor Inc., with whom Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July and a SARS-CoV-2 Rapid Antigen Test in September 2020. SD Biosensor is currently preparing to submit an Emergency Use Authorisation to the U.S. Food and Drug Administration (FDA).

As of January 29, 2021, the FDA authorized 320 coronavirus diagnostic tests, including 238 molecular tests, 69 antibody tests, and 13 antigen tests during 2020. Furthermore, 32 molecular authorizations can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter at-home antigen test.