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Roche Receives CE Mark for SARS-CoV-2 Nasal Antigen Test

NEW YORK – Roche announced on Monday that its SARS-CoV-2 Rapid Antigen Test Nasal received the CE mark and will launch by mid-February. 

Unlike Roche's existing rapid antigen test, the new test collects its sample from the front area of the nose instead of the nasopharynx, which is less invasive and can help reduce patient discomfort. The test also offers the option for self-collection of the nasal sample under the supervision of a healthcare professional, which can decrease the risk of exposure for frontline healthcare workers, Roche said in a statement.

Local regulatory requirements will dictate whether the test can be used without supervision of a healthcare professional, the company added.

The chromatographic immunoassay detects the nucleocapsid protein of the virus and showed sensitivity of nearly 91 percent and specificity of nearly 99 percent in samples collected by a professional, and sensitivity of 84 percent and specificity of 99 percent in self-collected samples during clinical studies, Roche said.

The test will be launched in partnership with SD Biosensor, with which Roche also launched its SARS-CoV-2 Rapid Antibody Test and the rapid antigen test. SD Biosensor is preparing to submit to the US Food and Drug Administration for Emergency Use Authorization, Roche said.