Swiss perspectives in 10 languages

Roche at-home Covid tests receive US FDA nod

covid test
The rapid at-home tests have been widely used in Switzerland since the spring. © Keystone / Christian Beutler

Swiss biopharma firm Roche has been granted emergency approval by US authorities to sell its at-home rapid Covid-19 test starting in January.

On Friday, Basel-based Roche announced that the US Food and Drug Administration has granted Emergency Use Authorisation for its at-home rapid test. The tests will be made available over-the-counter at pharmacies and retailers throughout the United States starting in January 2022.

“The Covid-19 pandemic continues to shed light on the critically important role that rapid self-testing plays in empowering individuals to protect their personal health and the health of their families and communities,” said Thomas Schinecker, CEO, Roche Diagnostics, in a press statementExternal link.

The Covid-19 At-Home Test uses a nasal swab sample to enable individuals to self-test at home and receive results in about 20 minutes for coronavirus and all known variants of concern, including Omicron.

The at-home tests or “self tests” have been widely used in Switzerland since this spring. For a period of time, a certain number of them were available to the population at no-cost. Studies of the accuracy of the results vary with some showing that the test detects positive cases when there is a high viral loadExternal link. One study from the University of Bern showed that the tests picked up 44% of symptom-free cases that were positive through a PCR test.

The company has a distribution agreement with SD Biosensor who has also been involved in the launch of a range of Covid tests. A key consideration for the authorisation, writes Roche, was its ability to deliver large quantities of tests and ramp up manufacturing to meet future demands. In a statement, the company said “it has the capacity to produce tens of millions of tests per month to help support the pandemic response”. 

Popular Stories

Most Discussed

News

No Swiss bank in phase with environmental objectives

More

Swiss banks failing environment, says WWF

This content was published on None of the 15 major Swiss retail banks is meeting international climate and biodiversity targets, according to a ranking by WWF Switzerland.

Read more: Swiss banks failing environment, says WWF
UNRWA provides emergency assistance to just over one million Palestine refugees, or about 75 per cent of all Palestine refugees in Gaza, who lack the financial means to cover their basic food.

More

Lazzarini: no alternative to UNRWA in Gaza

This content was published on The only alternative to the UN Palestinian agency’s work in Gaza is to allow Israel to run services there, Philippe Lazzarini, UNRWA Commissioner-General, told reporters in Geneva on Monday.

Read more: Lazzarini: no alternative to UNRWA in Gaza

In compliance with the JTI standards

More: SWI swissinfo.ch certified by the Journalism Trust Initiative

You can find an overview of ongoing debates with our journalists here . Please join us!

If you want to start a conversation about a topic raised in this article or want to report factual errors, email us at english@swissinfo.ch.

SWI swissinfo.ch - a branch of Swiss Broadcasting Corporation SRG SSR

SWI swissinfo.ch - a branch of Swiss Broadcasting Corporation SRG SSR