Following an accelerated review process, the U.S. Food and Drug Administration (FDA) last week approved two new over-the-counter COVID-19 tests in a two-month turnaround time, opening the market to millions of new Roche and Siemens tests.
“Increasing Americans’ access to easy-to-use, reliable COVID tests is a top priority for the Biden Administration, and we are using all resources at our disposal to make more tests available and ramp up supply,” Health and Human Services Secretary Xavier Becerra said. “Adding two new authorized tests will give Americans more options for testing at home, which helps keep people safe and provides peace of mind.”
Of these tests, one is manufactured by SD Biosensor and distributed by Roche, while the other is manufactured by Roche. Both have received emergency use authorization, and in both cases, their respective companies anticipate being able to produce tens of millions per month for use throughout the country. They represent the first tests to gain FDA authorization through the new Independent Test Assessment Program (ITAP), an HHS-invested effort to coordinate with the FDA and identify manufacturers with high-quality tests and major production capabilities.
“By rapidly conducting the precise studies recommended by the FDA, this program is shaving weeks to months off the typical EUA timeline,” Dr. Bruce Tromberg, director of the NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB) and RADx program lead, said.
RADx is the Rapid Acceleration of Diagnostics Technology program, run by the National Institutes of Health. For ITAP, experts from RADx work with FDA, Centers for Disease Control and Prevention, and other HHS specialists to quickly assess and study over-the-counter tests, giving companies a shortened timeframe to compile necessary data, advance their products and otherwise support their regulatory review.
“Knowing these tests have been independently assessed by NIH allows the FDA to act quickly on well-performed studies and trustworthy data that will lead to the availability of additional accurate and reliable tests at this critical time,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said.