FDA Provides Update on COVID-19 Diagnostic Review


As of March 30th, 20 emergency use authorizations have been granted for COVID-19 diagnostics.

The US Food and Drug Administration (FDA) has provided an update on the review processes and procedures for the authorization of coronavirus disease 2019 (COVID-19) diagnostic tests.

“It’s critical that the tests used work. False results can also contribute to the spread of COVID-19,” Stephen M. Hahn, commissioner of the FDA said. “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.”

According to the agency, the US Centers for Disease Control and Prevention (CDC) typically takes point on developing the first diagnostic when a novel health threat emerges since samples of the virus must be used to verify accuracy.

In the COVID-19 situation, the CDC and FDA worked collaboratively to combat problems with diagnostic manufacturing and used a commercial manufacturer to make the tests.

In late February, viral samples became available to test developers in the private sector when the National Institutes of Health’s partner, BEI Resources, began selling vials of the virus grown from materials provided by the CDC.

According to the FDA, once a developer has a viral sample, they can test the accuracy of their tests within 2 to 3 days. The agency notes that in the future it will be crucial to make viral samples available at an earlier point in order to deploy tests quickly.

The press release also contains a timeline of how the FDA has worked with test developers in the COVID-19 outbreak.

The agency began working with developers in January and to date has interacted 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 the FDA that they have begun using their own tests.

In order to encourage the development of tests, the FDA has 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.

The EUA program—when put into place by Congress—permits testing to be made available based on less data than in “non-urgent” circumstances and allows the FDA to conducted expedited reviews. According to the agency, EUA reviews can be conducted in as little as 1 day, which has been done several times for COVID-19.

In the update the agency also provides 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,” according to the statement.

In order to address the need for expanded testing, the FDA revised the process and permitted labs to begin testing prior to the agency’s review of their validation data. In the first week following the policy change, only 6 laboratories acted on the streamlined process.

The FDA states that uptake was considerably low because many laboratories did not have a test developed or did not have viral samples to assess the accuracy of their test.

In addition to the laboratory policy change, the FDA has also instituted a change to encourage states to take responsibility for tests that are developed and used by laboratories in their state without FDA review.

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