In a twist from last winter, when Americans waited hours at COVID-19 test sites and could not find rapid antigen tests during the omicron rise, coronavirus diagnostics in the United States – both over-the-counter and laboratory-based – are now widely available.
While The BA.2 subvariant is spreading in the United States, especially in the northeast, so far there are few signs of a COVID-19 increase on the scale seen below the omicron’s peak in January. Nevertheless, Quidel reported record sales of COVID-19 testing in the first quarter.
Quidel earlier this month said it expects First-quarter revenue in the range of $ 990 million to $ 1 billion, with CEO Doug Bryant claiming the company is “well positioned to deliver strong performance” for the year, targeting the professional, retail and public test markets.
Meanwhile, rival Abbott Laboratories was recently awarded a $ 1 billion contract by the U.S. Army to provide rapid COVID-19 antigen testing to the federal government as part of the Biden administration’s efforts to purchase one billion test kits at home to help meet future demand for testing.
Although the pandemic is not over yet, the Food and Drug Administration is putting together its plans for that eventuality.
In recent weeks, the agency has encouraged COVID-19 test developers to submit pre-market submissions for review to ensure that their diagnostic products can be marketed beyond the US public health emergency.
In particular, Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, has urged antigen test developers to pursue “conversions” of emergency use licenses (EUAs) to fully authorized versions of their products. “Go ahead and sit in line,” Stenzel said during a virtual town hall meeting in late March, adding that first submissions do not necessarily mean first out, depending on “whether further work may be needed.”
So far, the FDA has only given one again and 510 (k) approval for COVID-19 molecular tests. Although the agency has not yet given full marketing permission for antigen or serological tests, the FDA’s website says it is interested in doing so and that “a de novo submission would be the appropriate route for each of these.”
At the same time, the FDA has sought to reassure holders of EUAs for COVID-19 diagnostics and other equipment that it will give at least 180 days notice of its intention to terminate their approvals pending the cessation of public health emergency declarations.
Toby Lowe, associate director of regulatory programs at the FDA’s Office of In Vitro Diagnostics and Radiological Health, told a virtual town hall meeting earlier this month that the agency has no plans to “take any action that would leave the U.S. public without the tests they have.” need.”
The FDA recognizes that test manufacturers who have issued EUAs during the pandemic need an “appropriate transition period” when declaring emergencies under section 564 of the Federal Food, Drug and Cosmetic Act, which allows the agency to issue EUAs. , is no longer in force, Lowe said.
So far, the flow of emergency permits has not decreased. Late last week, the FDA assigned an EUA to the first COVID-19 test that detects chemical compounds associated with coronavirus in respiration.
Below is a collection of articles on the evolving COVID-19 test landscape. The collection will be updated in the future.