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Regulatory Focus™ > News Articles > 2020 > 3 > What Went Wrong With COVID-19 Testing? FDA Points to Slow Deployment of Commercial Tests

What Went Wrong With COVID-19 Testing? FDA Points to Slow Deployment of Commercial Tests

Posted 30 March 2020 | By Zachary Brennan 

What Went Wrong With COVID-19 Testing? FDA Points to Slow Deployment of Commercial Tests

As hospitals as well as state and commercial labs have now ramped up their testing for the novel coronavirus to almost 100,000 tests per day, many observers, including the US Food and Drug Administration (FDA) are looking back at the last two months wondering what took so long to get to this point.

A front-page article in Sunday’s New York Times explained how the virus spread for weeks without any testing, with experts pointing to early problems with the CDC’s first coronavirus test and a slow emergency use authorization (EUA) process within FDA as some of the reasons for the delay.

A look at the timeline shows how slowly the process moved: FDA issued an EUA for the CDC’s test on 4 February, but by the end of February only eight public health labs were using the CDC’s test. On 2 March, FDA allowed labs certified to perform high-complexity testing to offer their validated tests for a period of 15 days while they were preparing their EUA requests. But FDA says that in the first week after this change, only six laboratories took advantage of this further streamlined process because many did not have a test or did not have the viral samples to check the accuracy of their test. And according to the Guardian, from 8 March to the morning of 11 March, only 77 people in the US were tested.

But beginning the week of 9 March, commercial labs like Quest Diagnostics and LabCorp began to ramp up their testing. And by 17 March, FDA began allowing states to oversee certain tests, further relaxing its oversight. As of last Wednesday, the US was testing more than 100,000 per day.

So, in these early days and weeks, what caused the US to lag so far behind other countries like South Korea, which ramped up their testing quickly and took action earlier?

In its defense, FDA on Monday issued a statement noting: “FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic.” The agency also pointed to its EUA authority as “not a barrier to test availability,” and that EUA reviews can be conducted in less than a day.

But FDA explained that the CDC “encountered problems manufacturing their test,” and that FDA assisted “to resolve the issue and utilize a commercial manufacturer to make tests for any laboratory, not only public health labs.”

FDA also conceded that, “In the future, making viral samples available earlier to commercial developers will be crucial to deploying tests quickly. Moreover, CDC’s test should be manufactured by a commercial entity with the requisite expertise.”

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