In December, the Biden administration announced a plan to purchase 500 million at-home test kits and mail them for free to Americans who want them starting this month. Is there anything the government can do about it now? “They’re using them to keep the people around them safe, to ask the question - am I infectious right now? Am I a risk to my grandma, am I a risk to my neighbors?” Mina said. It also doesn’t make sense, given what most Americans are using rapid testing for. This process is expensive and ultimately provides no useful data to the agency, Mina said.
#CVS BINAX NOW TRIAL#
“The reality is, asking for a mathematical impossibility unless the company intentionally skews the participants in their trial and very carefully kind of curates or cherry-picks what participants are going to join their clinical trial,” Mina said. The FDA has asked companies to demonstrate that their rapid antigen tests are nearly as sensitive as PCR tests, which can return a positive test for more than a month after infection by detecting the presence of any amount of the virus’ genetic material.īut antigen tests - which look for the presence of proteins on the surface of the virus - are specific to when someone is infectious, and should only be positive when the person has a high viral load in their nose and throat, which sometimes only lasts around six days, Mina said. The FDA was receiving a lot of “bad tests,” he said.īut Michael Mina, epidemiologist and chief science officer at digital healthcare company eMed, said the FDA set unrealistic standards for rapid antigen tests that were incongruent with the purpose of frequent, rapid testing. Kocher said the tests being submitted early on simply didn’t work well enough. The director of the FDA office that authorizes tests, Tim Stenzel, told ProPublica the office received many applications that were either incomplete or had bad data, and any delays were due to careful review.
Denials took up to 186 days for applications submitted in April 2020. The firm found that the median number of days it took for the agency to issue a decision rose from 29 in April 2019 to 99 in November 2020.
In March, consulting firm Booz Allen Hamilton conducted an independent review of the emergency use authorization process, which allows the agency to approve medical devices and treatments quickly in a public health emergency. Many have pointed fingers at the FDA for its slow approval of rapid antigen tests early on in the pandemic. Is government red tape a factor in the shortage? “So when you think about testing, why are we testing? We’re not just testing to count the number of people, we’re testing to slow the spread of disease,” Aspinall said.
With the Omicron and Delta variants driving new infections, the transmission rate in Los Angeles County is now estimated to be greater than at any point since the early months of the pandemic. In the past year, vaccines have proven highly effective in preventing hospitalization and death from COVID-19 - but the coronavirus has shown it can evolve to be highly transmissible even in the vaccinated and cautious. Officials warn of price gouging as online marketplaces sell two-test packages for $75 or $80. “And if you go back a few months, before we had Omicron, and even Delta, there was a sense that OK, we have low numbers of cases in America, we’re vaccinating people, and COVID might go away.”īusiness Rapid COVID tests are reselling for triple the retail price “If you’re a test manufacturer, you’ve been reluctant to make tests that you’re not sure you’re going to sell,” said Kocher, a physician and venture capitalist who served in the Obama administration as special assistant to the president for healthcare and economic policy. So why aren’t they making enough tests?īob Kocher, who co-led California’s COVID-19 testing task force, said the rapid test shortage ultimately came down to a failure to anticipate demand. Coronavirus tests accounted for $510 million of Quidel’s roughly $635 million of revenue in the fourth quarter. For the third quarter of 2021, Abbott reported a year-over-year revenue gain of 23.4%, largely on the strength of $1.9 billion in global test sales. retail sales, according to an October earnings call. The earliest approved were tests produced by Abbott Laboratories and Quidel Corp., which received their emergency use authorizations from the Food and Drug Administration in March 2021.Ībbott’s tests alone account for about 75% of U.S. Half were approved between October and December. The Food and Drug Administration has authorized at least 12 rapid antigen tests that can be conducted at home without requiring a prescription. The Food and Drug Administration is responsible for authorizing medical tests. 10, 2022 An earlier version of this article incorrectly said the Centers for Disease Control had authorized at least 12 rapid antigen at-home antigen tests.
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