16th June 2021

Roche receives CE mark for at-home nasal test

Roche has received the 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.

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 check if they are likely to be infectious from 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 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 personalised 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.

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

Geoff Twist, general manager of Roche Diagnostics UK and Ireland, said: “As we navigate the careful road to recovery from this pandemic, accurate testing for COVID-19 will continue to have a critical role to play in allowing normal activities to resume safely and with confidence.

“Our new nasal antigen self-test provides results in as little as 15 minutes and has the added advantage of only requiring a sample from the lower part of both nostrils – making it relatively easy and less uncomfortable to perform. It is also supported by a digital solution which allows individuals and healthcare professionals to securely store and display their COVID-19 test results.”