Roche Rapid Antigen Test
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Basel, December 24, 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its At-Home Test.
Test uses a simple nasal swab sample that can be easily self-collected and tested by individuals 14 years of age and older, and by an adult for children 2-13 years old.² The test can provide accurate, reliable, and rapid results in just 20 minutes for and all known variants of care, including Omicron.
The FDA's EUA decision stems from Roche's participation in the National Institutes of Health's (NIH) Rapid Acceleration of Diagnostics (RADx) Independent Test Assessment Program (ITAP), which aims to provide regulatory assessment and availability of high quality, accurate and reliable OTC testing for the US public.
The At-Home test was prioritized by the FDA based on Roche and SD Biosensor's ability to deliver large volumes of high-quality testing and ramp up production to meet future requirements.
As of January
The At-Home Test will be available in the United States and in accordance with local guidelines and testing strategies. At launch, Roche has the capacity to produce tens of millions of tests per month to support the pandemic response. The At-Home Test provides a convenient frequent testing option without the need to visit a healthcare provider.
“The pandemic continues to shed light on the critical role rapid self-tests play in empowering individuals to protect their personal health and the health of their families and communities,” said Thomas Schinecker, CEO of Roche Diagnostics. . “At this turning point in the American public's fight against , we are proud to have worked closely with the US government to introduce and expand access to accurate, reliable and high-quality home testing.”
“Expanding access to rapid testing solutions to all patients in the United States is critical to public health and the pandemic response,” said Matt Sause, President & CEO of Roche Diagnostics North America. “As long as the need for reliable testing continues, Roche will continue to invest in effective solutions to ensure testing options are available to those who need them.”
Along with the At-Home Test, Roche will offer NAVIFY Pass as a solution for organizations that want to enable individuals and caregivers to remotely and securely store, display and share results. All At-Home Tests come with a unique data matrix, allowing NAVIFY Pass to automatically match individuals' test results to their respective test devices.
The launch will be in partnership with SD Biosensor Inc.
with whom Roche has a global distribution agreement and has previously launched a series of tests in 2020 and 2021 in countries outside the US that accept the CE marking, including the Rapid antigen testing (nasopharyngeal/nasal), nasal antigen self-test, rapid antibody test and & flu A/B rapid antigen test.
The test will be the first rapid antigen test for to receive FDA emergency use authorization, and sixth rapid test in total to accompany Roche's comprehensive portfolio of diagnostic solutions to help healthcare systems around the world fight the pandemic through lab testing and on-site care. Roche Diagnostics' portfolio includes a wide range of molecular, rapid serology and digital solutions that help diagnose and manage during the initial stages of infections, during the recovery phase and after infection has cleared.
About the Home Test2
The At-Home Test is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein present in anterior nasal swabs. In a prospective clinical study, the At-Home Test showed a relative sensitivity of 95.3% (95% CI: 84.5 to 98.7%) and a relative specificity of 100% (95% CI: 95, 7 to 100%). A total of 138 symptomatic subjects participated in the studies (128 evaluable samples).
This test is intended for*: 1) over-the-counter (OTC) home use within the first 6 days of symptom onset; 2) Over-the-counter home use with or without symptoms or other epidemiological reasons to suspect when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.