FDA Grants EUAs for Roche COVID-19 At-Home Test, Siemens Healthineers COVID-19 Antigen Self-Test

The FDA has granted emergency use authorization for a COVID-19 at-home test (Roche) and a rapid COVID-19 antigen self-test (Clinitest; Siemens Healthineers).

The FDA has granted emergency use authorization (EUA) for a COVID-19 at-home test (Roche) which uses an anterior nasal swab sample that can be self-collected and self-tested by individuals 14 years of age and older and by an adult for children between 2 and 13 years of age. The test can produce reliable, quick results in approximately 20 minutes for SARS-CoV-2 and all known variants of the virus.1

"Expanding access to rapid testing solutions for all patients in the United States is essential to public health and the pandemic response,” said Matt Sause, president and CEO of Roche Diagnostics North America, in a press release.1

Additionally, a rapid COVID-19 antigen self-test (Clinitest; Siemens Healthineers) was granted an EUA and is authorized for self-testing use by individuals 14 years of age and older or adult-collected samples from individuals between 2 to 13 years of age. This antigen self-test uses a nasal swab to rapidly detect SARS-CoV-2, according to a press release.2

“The CLINITEST rapid COVID-19 antigen self-test detects SARS-CoV-2 antigens in people who are actively infected with the virus, making important information more readily available,” said Christoph Pedain, PhD, head point of care diagnostics at Siemens Healthcare, in the press release. “We’d like to thank the US Government, specifically the National Institutes of Health Rapid Acceleration of Diagnostics’ Independent Test Assessment Program, for their partnership in bringing much needed tests to the American people. We know this is a critical time in this pandemic, and we will do our part in providing support.”2

Both tests will be available starting in January in the United States in accordance with local guidelines and testing strategies. Furthermore, both tests offer a convenient, fast testing option for patients that helps them circumvent a health care provider’s office or an emergency department for testing.1,2

REFERENCES

  1. Roche COVID-19 At-Home Test granted FDA Emergency Use Authorization to expand access to rapid self-testing solutions in the United States. Roche. December 24, 2021. Accessed January 3, 2022. https://www.roche.com/investors/updates/inv-update-2021-12-24.htm
  2. Siemens Healthineers Announces FDA Emergency Use Authorization for CLINITEST Rapid COVID-19 Antigen Self-Test. BusinessWire. December 29, 2021. Accessed January 3, 2022. https://www.businesswire.com/news/home/20211229005379/en