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Roche Gets CE Mark for SARS-CoV-2 Antigen Self Test

NEW YORK – Roche announced on Tuesday that its SARS-CoV-2 Antigen Self Test Nasal has received CE marking for at-home testing.

Users can test themselves at home with a nasal swab, and the test will be available in packs of five through pharmacies and other locations depending on local guidelines, the company said in a statement. An earlier version of the test has been available as a home-test since February in specific European markets, including Germany, under local special approval pathways.

The lateral flow test, which was developed in partnership with Korean diagnostics firm SD Biosensor, provides results in about 15 minutes and can be performed without special training or the supervision of a healthcare professional. For children under 18, the test must be performed by an adult or under close adult supervision, Roche said. The test received the CE mark in February for professional use.

In a head-to-head comparison with Roche's RT-PCR test, the antigen test had relative sensitivity of 91 percent and relative specificity of nearly 100 percent.

"As the world prepares to reopen, high-quality, home-based testing will play an important role in the battle against the pandemic," Roche Diagnostics CEO Thomas Schinecker said in a statement.

Roche previously launched a SARS-CoV-2 Rapid Antibody Test and two SARS-CoV-2 Rapid Antigen Tests for professional use with SD Biosensor.

Roche is also offering its Navify Pass digital solution that lets users store, display, and share their COVID-19 test results and vaccine status with a personalized QR code.