The U.S. Food and Drug Administration (FDA) has authorized Roche and Siemens At-Home Tests which will bring tens of millions of new tests per month to the U.S.
The tests, one manufactured by SD Biosensor and distributed by Roche and the other manufactured by Siemens, have received emergency use authorization (EUA) by the Food and Drug Administration (FDA) after being evaluated through the Administration’s new accelerated pathway to support FDA review of tests with potential for large-scale manufacturing that the Department of Health and Human Services (HHS) announced just two months ago.
These quick authorizations are with collaboration between the FDA and the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics Technology (RADx) program.
In late October, HHS announced the Administration would invest $70 million from the American Rescue Plan to help bring more high-quality, at-home tests onto the market in the U.S. in coordination with FDA. This new Independent Test Assessment Program (ITAP) is helping identify manufacturers of high-quality tests and encouraging them to bring those tests to the U.S. market, increasing options for people and overall supply and potentially lowering costs.
Additionally, there are now 20,000 free testing sites across the U.S., four times as many at-home tests available to Americans than were available this summer, and free at-home tests are already being made available at key community sites, such as community health centers and rural clinics.
