Roche (SWX: RO, ROG) announced today that it received CE Mark approval for its new SARS-CoV-2 nasal rapid antigen test.
Basel, Switzerland-based Roche’s nasal test collects the sample from the front area of the nose instead of the nasopharynx, which is the method used with its existing SARS-CoV-2 rapid antigen test. The new method results in a simplified and faster testing procedure, according to a news release.
The new method can help reduce overall patient discomfort, particularly in sensitive individuals such as children, elderly people and those with disabilities, Roche added.
Additionally, the test offers patients the option to self-collect under the supervision of a healthcare professional, decreasing the risk of exposure to the virus for those administering the tests. Using the tests without the supervision of a healthcare professional depends on local regulatory requirements.
Roche is launching the test in partnership with SD Biosensor, which is planning submit the test for FDA emergency use authorization (EUA), too.
“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.” Roche CEO Thomas Schinecker said in the release. “The SARS-CoV-2 rapid antigen test nasal provides patients with a more comfortable testing experience.”