The U.S. government continues to push for more at-home screening to combat the spread of COVID-19 as a winter surge and the contagious delta and omicron variants have pushed the country’s daily case numbers to all-time highs.
The FDA authorized its second major self-diagnostic in less than a week, while the Department of Defense (DOD) inked a multimillion-dollar contract to set up a new plant for manufacturing rapid testing strips.
After granting a green light to a 20-minute home test produced by Roche and its distribution partner SD Biosensor on Dec. 24, the FDA has now given its thumbs-up to Siemens Healthineers’ over-the-counter antigen screening kit.
Siemens’ Clinitest uses a nasal swab and can be performed by anyone over age 14. The company said it expects to be able to ship tens of millions units per month to U.S. retailers, with availability starting in January 2022.
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Like Roche’s product, Siemens’ screener graduated from the expedited test assessment program being run by the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative, also known as RADx. Both tests were evaluated for their potential to quickly scale up to mass production to help meet nationwide demand. Their accuracy was independently verified before the companies received an FDA emergency use authorization, or EUA.
“By rapidly conducting the precise studies recommended by the FDA, this program is shaving weeks to months off the typical EUA timeline,” RADx program lead Bruce Tromberg, Ph.D., director of the NIH’s National Institute of Biomedical Imaging and Bioengineering, said in a statement.
The NIH previously invested $70 million in the independent test assessment program when it launched in late October. The team has tapped experts at the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services for assistance.
“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,” the FDA’s device center director, Jeff Shuren, M.D., said in a statement.
“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.
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Meanwhile, the DOD has contracted with Merck KGaA for a three-year, $137 million (121 million euro) project to build a new lateral flow membrane production facility at its Wisconsin location.
These membranes draw sample liquids across the testing strip and are an essential part for a variety of rapid diagnostics manufactured by other companies—including for COVID-19 as well as for influenza, malaria, HIV and more.
German Merck previously invested in a second membrane production line at its facility in Cork, Ireland. During the pandemic, the company has expanded its range of reagents and other raw materials for assembling lateral flow test kits.
Earlier this month, the Biden administration said it would purchase 500 million rapid coronavirus tests and distribute them for free starting in January 2022. Since then, a combination of the delta and omicron variants has triggered a wave of new infections, with an average of more than 265,000 per day in the U.S. Omicron now accounts for about 60% of new cases after it was first detected in the U.S. in early December, according to the CDC.