FDA allows new coronavirus testing tech before it gets emergency approval
By Jon Fingas
The FDA is determined to step up the pace of coronavirus testing in the US to cope with the recent coronavirus outbreak, and it's willing to greenlight technology at an early stage to make that happen. The regulator said it will allow new diagnostic tech to be used to test for COVID-19 before an Emergency Use Authorization request has gone through a review. This will only apply to validated methods from labs that are certified to handle "high-complexity" tests in line with key requirements, the FDA said, and doesn't amount to lowering standards -- this is only to ensure there's "wide availability" of testing options.
There's currently just one emergency authorization for COVID-19 in use by the CDC and public health labs, the FDA added. Early US tests were hurt by kits that included a bad reagent that rendered the tests ineffective.
To some degree, this is damage control. On top of the problems with early tests, there have been criticisms of the safety behind the evacuation process and the ability of scientists to speak freely about the current situation. Still, the expedited access could significantly improve testing and give a clearer assessment of who's infected.
Via: TechCrunch
Source: FDA
March 1, 2020 at 01:06AM
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