The Biden administration is taking steps to boost access to over-the-counter Covid-19 testing, the Department of Health and Human Services announced Monday.
That includes a $70 million investment from the National Institutes of Health via the Covid relief package passed earlier this year to bring more tests onto the market by identifying and encouraging new manufacturers.
The White House has been increasing its investment in at-home Covid testing recently, but demand has outpaced supply for those tests so far, with shelves empty across the country. The administration is seeking to quickly ramp up that supply.
“NIH’s new Independent Test Assessment Program (ITAP) will establish an accelerated pathway to support FDA evaluation of tests with potential for large-scale manufacturing,” HHS said in a statement.
The US Food and Drug Administration will also streamline the regulatory process for manufacturers of at-home, over-the-counter tests.
“Access to easy-to-use, affordable and reliable COVID tests is key to bringing peace of mind to our families, especially as we approach winter. Thanks to President (Joe) Biden’s American Rescue Plan, we are boosting the supply of at-home tests and the number of test options for Americans nationwide,” HHS Secretary Xavier Becerra said in a statement Monday.
Earlier in this month, the White House announced a $1 billion investment in purchasing rapid at-home Covid-19 tests to put on the market in an effort to make testing faster, easier and cheaper.
In September, President Joe Biden announced a $2 billion investment in rapid testing for community health centers, food bank and schools, and also announced that retailers including Walmart, Amazon and Kroger will sell at-home rapid test kits at cost for the next three months.
Earlier this month, the US Food and Drug Administration authorized Flowflex, an at-home antigen test from ACON laboratories, which will accelerate the pace of rapid tests hitting the shelves.
The Flowflex test authorization, the FDA said in a statement, “should significantly increase the availability of rapid, at-home tests and is expected to double rapid at-home testing capacity in the U.S. over the next several weeks.”
While the US was previously on track to double the supply of rapid at-home tests available on the market each month by early November, White House Covid-19 response coordinator Jeffrey Zients said in early October the authorization of the ACON laboratories test “accelerates this pace and we are now on track to triple the number by early November.” The new commitments by manufacturers, he said, “puts us on track to quadruple the amount of at-home rapid tests available for Americans by December.”
There are several types of diagnostic tests, including antigen tests, which are generally faster and more affordable, and can be performed alone at home or with a virtual aide, or may be administered by a doctor or pharmacist. The “gold standard” of Covid-19 tests are rt-PCR tests, a type of nucleic acid amplification test, which are highly accurate and detect genetic material from the virus.