The U.S. Food and Drug Administration has granted an Emergency Use Authorization for a COVID-19 At-Home Test developed by Roche Diagnostics. The company says the test will be available across the country beginning in January.
Roche says the test uses a simple anterior nasal swab sample that can be self-collected and self-tested by individuals as young as 14 years-old, and by an adult for children between ages 2-13. The test is designed to produce results in as few as 20 minutes for the virus that causes COVID-19 and all known variants, including Omicron.
“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,” Thomas Schinecker, chief executive officer of Roche Diagnostics, said in a news release. “At this inflection point in the American public’s fight against COVID-19, we are proud to have worked in close collaboration with the US Government to introduce and expand access to accurate, reliable and high-quality at-home tests.”
The EUA is the result of Roche’s participation in the National Institutes of Health Rapid Acceleration of Diagnostics’ Independent Test Assessment program. Roche says it has the capacity to produce tens of millions of tests per month.
Last year, Roche received an EUA for its COVID-19 antibody test, which is used to help determine if someone has been exposed to the SARS-CoV-2 virus and if they’ve developed antibodies against it.