Skip to main content
Premium Trial:

Request an Annual Quote

Roche Obtains FDA Emergency Use Authorization for COVID-19 Antigen Self-Test

NEW YORK ─ Roche announced on Friday that it has obtained US Food and Drug Administration Emergency Use Authorization for its COVID-19 At-Home Test to expand access to rapid self-testing in the US.

The test, Roche's first rapid antigen assay for SARS-CoV-2 to receive such an authorization, will be available to purchase over-the-counter at US pharmacies and retailers starting in January.

The COVID-19 At-Home Test ─ a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 in anterior nasal swab samples ─ enables individuals to self-test at home and receive results in about 20 minutes for SARS-CoV-2 infection and all known variants of concern, including Omicron, Roche said.

Samples can be self-collected and self-tested by individuals aged 14 years and older, and by an adult for children aged 2 to 13 years old.

The test is intended for use within the first six days of symptom onset, or with or without symptoms or other epidemiological reasons to suspect COVID-19. In the latter intended use, an individual must be tested twice over three days with at least 24 hours and no more than 48 hours between tests.

The COVID-19 At-Home Test showed a relative sensitivity of 95.3 percent and relative specificity of 100 percent in a prospective clinical study, Roche said.

The Basel, Switzerland-based company will launch the test in partnership with South Korean firm SD Biosensor with whom it has a global distribution agreement and has co-launched numerous CE marked tests throughout 2020 and 2021.

The partners' ability to deliver large quantities of tests and ramp up manufacturing to meet future demands led to the FDA prioritizing the authorization, Roche said, adding it has the capacity to produce tens of millions of tests per month to help support the pandemic response.

The company will offer Navify Pass, a digital application, with the COVID-19 At-Home Test to organizations that want to allow individuals and healthcare professionals to store, display, and share results. All of the tests will be supplied with a unique data matrix that enables Navify Pass to automatically link individuals’ test results to their test devices.

Roche noted it obtained EUA through its participation in the National Institutes of Health Rapid Acceleration of Diagnostics (RADx) Independent Test Assessment Program (ITAP), established to bring rapid, over-the-counter tests to market in the US.