FDA Grants Emergency Use Authorization For Roche’s At-Home COVID-19 Test

Multinational healthcare company Roche has been given an Emergency Use Authorization by the FDA for its at-home rapid COVID-19 test. The test, soon to be available over-the-counter at pharmacies and select retailers in the U.S., uses a home-testing-friendly nasal swab sample procedure that produces results in roughly 20 minutes for all known variants of COVID-19, including the recent, quickly spreading Omicron.

Roche Diagnostics Chief Executive Officer Thomas Schinecker said, “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." Basel-based Roche is surely aware that Switzerland has seen an upsurge in the popularity of at-home tests since spring of 2021. At one point, a limited number of free-of-charge self tests were available to the country's population.

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To facilitate the launch of the Covid-19 At-Home Test, Roche has inked a distribution agreement with SD Biosensor, which has previously had a hand in many other COVID-19 test launches. When vying for the FDA's Emergency Use Authorization, Roche was optimistic about the potential opportunity to deliver mass quantities of tests and scale up its manufacturing to meet increased demand. The company said “it has the capacity to produce tens of millions of tests per month to help support the pandemic response."