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Roche Obtains CE Mark for Next-Gen SARS-CoV-2 Rapid Antigen Tests

NEW YORK – Roche announced on Wednesday that it has received CE marking for three new versions of its SARS-CoV-2 rapid antigen tests.

Distribution of the tests is expected to begin in the next few weeks, Roche said in a statement. The SARS-CoV-2 Rapid Antigen Test 2.0 relies on nasopharyngeal swabs and is cleared for professional use, and the SARS-CoV-2 Rapid Antigen Test 2.0 Nasal assay uses nasal swabs and is also cleared for professional use. Both tests are rapid chromatographic immunoassays for qualitative detection of the nucleocapsid protein of SARS-CoV-2 and are intended for use in laboratories or near-patient testing environments, Roche said.

Meantime, the SARS-CoV-2 Antigen Self Test Nasal is a lateral flow test to qualitatively detect the nucleocapsid antigen and is cleared for self-testing using nasal swabs. 

The tests have an improved capture antibody, and all work with the firm's Navify Pass digital solution to store COVID-19 vaccination status and test results. The tests will be introduced in partnership with SD Biosensor, and Roche has the capacity to provide "several tens of millions of each of the tests per month, with the option to quickly build up additional capacity if needed," it said. 

Roche has previously received CE marking for multiple SARS-CoV-2 antigen tests developed with SD Biosensor, including the first version of the nasopharyngeal test in September 2020, the first version of the nasal antigen test in February 2021, and the self test in June 2021.

Lab testing showed that all three tests can detect major variants of concern, including the Delta and Omicron variants, Roche said.