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FDA Grants Emergency Authorization to Roche’s At-Home COVID-19 Test
The at-home COVID-19 test can produce accurate results in as little as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron.
FDA recently granted emergency use authorization to Roche’s COVID-19 At-Home Test for children aged 14 years and older and by an adult for children aged two to 13 years.
The COVID-19 At-Home Test can produce accurate results in as little as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron.
The test showed a relative sensitivity of 95.3 percent and a relative specificity of 100 percent in a prospective clinical study.
FDA authorized the test for non-prescription home use within the first six days of symptom onset and non-prescription home use with or without symptoms or other epidemiological reasons to suspect disease.
“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, CEO of Roche, said in the announcement.
“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,” Schinecker continued.
FDA based its decision on Roche’s participation in the NIH Rapid Acceleration of Diagnostics’ (RADx) Independent Test Assessment Program (ITAP), which aims to boost regulatory review and availability of high-quality, accurate, and reliable over-the-counter tests.
The agency prioritized review of the test based on Roche and SD Biosensor’s ability to deliver large quantities of high-quality tests and increase manufacturing to meet future demands.
Last year, Roche tapped SD Biosensor to launch two of its SARS-CoV-2 Rapid Antibody Tests.
The tests aimed to identify individuals who had been infected by COVID-19, especially those who did not display symptoms. The test also screened high-risk groups so they could return to work safely.
All tests are supplied with a unique data matric to automatically link individuals’ test results to their respective test devices.
The COVID-19 At-Home Test will be available across the US starting in January, in accordance with local guidelines and testing strategies.
And Roche will offer NAVIFY Pass along with the test as a solution to organizations who want to allow individuals and healthcare professionals to securely store, display, and share results.
