The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Roche’s COVID-19 At-Home Test.¹
The test uses an anterior nasal swab sample that can be self-collected and self-tested by individuals aged 14 years and older, and by an adult for children aged 2-13 years old.² The test is able to produce accurate, reliable, and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron.
The FDA’s EUA decision stems from Roche’s participation in the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics’ (RADx) Independent Test Assessment Program (ITAP), which aims to accelerate the regulatory review and availability of high-quality, accurate and reliable OTC tests to the American public. The COVID-19 At-Home Test was prioritized by the FDA based on Roche and SD Biosensor’s ability to deliver large quantities of high-quality tests and ramp up manufacturing to meet future demands.
Starting in January, the COVID-19 At-Home Test will be available across the United States and in accordance with local guidelines and testing strategies. Roche says it has the capacity to produce tens of millions of tests per month to help support the pandemic response.
“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,” says Thomas Schinecker, CEO, Roche Diagnostics. “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.”
Together with the COVID-19 At-Home Test, Roche will offer NAVIFY Pass as a solution to organizations who want to allow individuals and health care professionals to remotely and securely store, display, and share results. All COVID-19 At-Home Tests are supplied with a unique data matrix, enabling NAVIFY Pass to automatically link individuals’ test results to their respective test devices.
“Expanding access to rapid testing solutions for all patients in the United States is essential to public health and the pandemic response,” says Matt Sause, president & CEO of Roche Diagnostics North America. “As long as there remains a need for reliable testing, Roche will continue to invest in effective solutions to ensure there are testing options available to those who need them.”
The launch will be in partnership with SD Biosensor Inc., with whom Roche has a global distribution agreement and previously launched a range of tests throughout 2020 and 2021 in countries outside of the U.S. that accept the CE Mark, including the SARS-CoV-2 Rapid Antigen Tests (Nasopharyngeal/Nasal), SARS-CoV-2 Antigen Self Test Nasal, SARS-CoV-2 Rapid Antibody Test and SARS-CoV-2 & Flu A/B Rapid Antigen Test.3
 This product has not been FDA cleared or approved, but has been authorized by the FDA under an EUA for non-prescription home use (OTC) with self- and adult-collected anterior nasal swab samples. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
 SD Biosensor. (2021). COVID-19 At-Home Test package insert.
 CE Mark obtained on 21 December 2021 for the SARS-CoV-2 & Flu A/B Rapid Antigen Test.