FDA Approves Two New Over-the-Counter At-Home COVID-19 Tests

WASHINGTON — Two new over-the-counter COVID-19 tests intended for home use have been approved by the Food and Drug Administration.

Both of the tests, one manufactured by SD Biosensor and distributed by Roche and the other manufactured by Siemens, are expected to be on the market in January.

According to the White House, they received emergency use authorization by the FDA after being evaluated through the administration’s new accelerated pathway to support agency review of tests with potential for large-scale manufacturing.

In an email, the administration officials credited the quick authorizations to a collaboration between the FDA and the National Institutes of Health Rapid Acceleration of Diagnostics Technology program. 

Combined, the White House said, it is estimated the companies can produce tens of millions of tests per month for use in the United States. 

“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,” said Health and Human Services Secretary Xavier Becerra in a written statement.

“Adding two new authorized tests will give Americans more options for testing at home, which helps keep people safe and provides peace of mind,” he said.

Both the Siemens Healthineers and Roche/SD Biosensor tests use a simple anterior nasal swab sample that can be conveniently self-collected and self-tested by individuals aged 14 years and older, and by an adult for children aged 2-13 years. 

The Roche/SD Biosensor test is able to produce accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including omicron, the company said in a press release.

“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,” said Thomas Schinecker, CEO of Roche Diagnostics. 

“At this inflection point in the American public’s fight against COVID-19, we are proud to have worked in close collaboration with the U.S. government to introduce and expand access to accurate, reliable and high-quality at-home tests,” he said.

The Siemens test, manufactured by Siemens Healthineers, is also an easy-to-use nasal swab test and provides visually read test results in just 15 minutes. 

“Undetected COVID-19 exposure is a major driver of community spread. With the CLINITEST Rapid COVID-19 Antigen Self-Test, consumers will have access to a fast, reliable, and convenient test to provide additional safety,” said Christoph Pedain, PhD, head of point of care diagnostics, Siemens Healthineers. 

“Siemens Healthineers is proud to bring this high-quality test, already used and trusted by families, medical professionals, businesses and governments in many parts of the world, to the United States under FDA Emergency Use Authorization,” Pedain said.

In late October, the Department of Health and Human Services 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 the FDA. 

This new Independent Test Assessment Program 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, the White House said.

In this new program, NIH’s RADx Tech network of experts from government, academia, and industry work together with the FDA, CDC and other HHS specialists to assess and conduct studies on over-the-counter tests.

This coordinated effort allows companies to compile proper data, work towards the right benchmarks for performance, and support other needs that will help ensure they are providing the best submissions possible for FDA’s regulatory review. 

The goal is to accelerate the availability of more high-quality, accurate and reliable over-the-counter tests to the public as quickly as possible. The tests by Roche and Siemens are the first to gain FDA authorization through this program.

“This program is incredibly beneficial to increasing access to rapid tests by quickly and consistently gathering the critical data companies need to request EUA and subsequently enter the U.S. market once authorized,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. 

“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,” Shuren said.

On a related note, the Defense Department, in coordination with the Department of Health and Human Services, awarded a $136.7 million contract on Wednesday to boost the production of a key component of rapid, over-the-counter COVID tests.

The funding was awarded to MilliporeSigma, of Sheboygan, Wisconsin, to enable it to establish nitrocellulose manufacturing capability in its existing facilities.

Nitrocellulose membrane is a critical material used in manufacturing SARS-CoV-2 rapid point-of-care tests. 

The investment will allow MilliporeSigma to produce more than 83.3 million tests per month, the Defense Department said.

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue.