In July of 2020 in Frequent, Fast and Cheap is Better than Sensitive, I wrote:
Various corporations have developed low cost, paper-strip checks for coronavirus that report outcomes at-home in about quarter-hour however they’ve but to be permitted to be used by the FDA as a result of the FDA seems to be demanding that each one checks attain accuracy ranges much like the PCR check. That is one other lethal FDA mistake.
It’s miserable that we’re nonetheless transferring so slowly on these points however the media has lastly gotten on board. Earlier I discussed David Leonhardt’s article. Right here is Margaret Hartmann within the New York Magazine.
In lots of Asian and European nations, at-home COVID-19 checks are low cost and simple to seek out in shops. CBS Information reported this month that dwelling antigen checks at the moment are used routinely within the U.Ok., the place they’re free and “available at just about each pharmacy within the nation.”
The scenario is drastically completely different right here as a result of U.S. well being officers targeted on getting individuals vaccinated in opposition to COVID-19 and by no means leaned into asymptomatic testing as a technique to battle the pandemic. Whereas some overseas governments moved shortly to encourage screening and subsidize the price of at-home checks, the Meals and Drug Administration’s approval course of moved much more slowly.
….The FDA mentioned it wanted to make sure that the checks have been correct, however many scientists countered that the company was letting the proper be the enemy of the great.
Be aware additionally that this can be a means of claiming that the politicians have now additionally had it with the FDA:
Along with ramping up manufacturing of checks already available on the market, the federal government can be working to hurry up the approval course of. On October 4, the FDA authorized Flowflex, an at-home antigen check produced by ACON Laboratories that’s anticipated to retail for round $10 per check. And on October 25, the Division of Well being and Human Providers announced that the FDA will streamline its authorization course of, and the Nationwide Institutes of Well being will spend $70 million on a brand new program to “set up an accelerated pathway” to help check makers looking for approval for his or her merchandise.