Industry News: Roche obtains CE mark for the SARS-CoV-2 Antigen Self-Test Nasal allowing for rapid self-testing of COVID-19 at home

The test will be widely available to individuals through pharmacies and other locations in accordance with local guidelines and testing strategies

10 Jun 2021


Roche has announced that it has received CE mark for its SARS-CoV-2 Antigen Self-Test Nasal for at-home testing. The test will be available in countries accepting the CE mark through pharmacies and other locations, in packs of five tests. 

An early version of the test has already been available as a home-test in a number of European markets under local special approval pathways since February 2021. With the CE Mark, the SARS-CoV-2 Antigen Self-Test Nasal for rapid self-testing of COVID-19 test has received official approval following the traditional registration pathway and can now also be used in markets that have not established regulatory exemption pathways. 

By following simple instructions, individuals can perform the test at home using a nasal swab without special training or the supervision of a healthcare worker. The test provides results in as little as 15 minutes and can help people to conveniently check if they are likely to be infectious from the comfort of their home. In the case of children under 18 years of age, the test must be performed by an adult or under close adult supervision.

As societies begin to reopen and in line with local health regulations, the convenient test allows individuals planning to attend an event or gathering to use the test as a tool to confirm that they are not likely to be carriers of a substantial amount of the virus thus helping them make informed decisions and reduce the risk of transmission to others. 

Complementary to the SARS-CoV-2 Antigen Self-Test Nasal, Roche is offering NAVIFY® Pass. This digital solution allows individuals and healthcare professionals to remotely store, display, and share their COVID-19 test results and vaccine status through a personalized QR code. Having easy digital access to test results and vaccination status could potentially be used by both individuals and companies to facilitate access to locations with COVID-19 entry protocols, such as restaurants or entertainment venues, as well as to validate safety to travel.

“As the world prepares to reopen, high-quality, home-based testing will play an important role in the battle against the pandemic,” said Thomas Schinecker, CEO, Roche Diagnostics. “Regular self-testing at home can reduce pressure on healthcare systems. It can quickly identify people with the highest potential to be infectious so they can take immediate action to seek medical advice, manage their infection and protect others.”

This test is part of a partnership with SD Biosensor Inc., with whom Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July 2020 and two SARS-CoV-2 Rapid Antigen Tests for professional use in September 2020 and February 2021. These tests will continue to play an important role in fighting this pandemic and remain available for healthcare professional testing.

In addition to diagnostic testing, preventive measures remain key to protecting yourself and others against SARS-CoV-2. It is recommended to continue wearing masks, socially distance and practice good hygiene, especially if you have symptoms or known contact with others who have tested positive for the virus. 

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