FDA Accelerates Review of COVID-19 Diagnostic Tests

March 31, 2020 - FDA Commissioner Stephen M. Hahn, MD, recently provided an update on the review processes and procedures for the authorization of COVID-19 diagnostic tests.

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Test accuracy is vital during the coronavirus outbreak, as false results can contribute to the spread of the virus. Therefore, FDA stressed that it will expedite reviews of diagnostic tests to combat COVID-19, Hahn said in the latest update on the agency’s website.

“The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic,” said Hahn.

“We want our treatments to be tested for effectiveness and reviewed by the FDA. We want the same for our tests—assurances that they are accurate and effective.”

Typically, the CDC will develop the first diagnostic test when a novel health threat emerges since samples of the virus are crucial to confirm the accuracy of the test.

For COVID-19, viral samples were available to private sector test developers in late February when the National Institutes of Health partner, BEI Resources, sold vials of the virus that originated from materials provided by the CDC.

According to Hahn, once a developer has a viral sample, they can test the accuracy of their tests within two to three days. In the future, it will be crucial to make viral samples available at an earlier point in order to deploy tests quickly.

“As in previous emergencies, the FDA has been extremely proactive and supportive of test development by all comers-laboratories, and large and small commercial manufacturers-offering our expertise and support to speed development and to quickly authorize tests that the science supports,” Hahn highlighted.

The update emphasized that FDA will continue to work with test developers during the COVID-19 outbreak to slow and ultimately tackle the virus.

Since the beginning of January, the agency has worked with 230 test developers who have or are expected to submit requests for emergency use authorization (EUA). As of March 30th, 20 authorizations have been granted. Additionally, more than 110 laboratories have notified FDA that they have begun using their own tests.

For interested developers, FDA provided recommendations on evaluating test accuracy and has also put together a form for developers to easily share test information to expedite the process of the EUA.

EUA authority is not a roadblock to test availability, Hahn said. Put into place by Congress, EUA allows tests to be made available based on less data than in non-urgent situations. The regulation enables FDA to conduct quick and efficient reviews. Most times, FDA is able to complete a review in a day.

In the update, FDA also provided policy updates for COVID-19 diagnostics. 

“The FDA recognized the urgent need for even faster testing availability. Although laboratories could use the EUA pathway, many were hesitant or didn’t know the pathway was available to them.”

To respond to the urgent testing needs, FDA revised the process to allow labs to begin testing prior to FDA review of their validation data. In the first week following the policy change, six laboratories acted on the improved process due to lack of test or viral samples to check the accuracy of the test.

The policy update also included a change to empower states to take responsibility for tests developed and used by laboratories in their states without FDA review.

“Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed,” Hahn stated.