Monkeypox Update: New FDA Testing Guidelines as the US Passes 20,000 Cases

On September 7, the United States Food and Drug Administration (FDA) announced steps to further increase monkeypox testing capacity and accessibility nationwide. The FDA testing guidelines update comes on the same day that the United States monkeypox cases surpassed 20,000, the most of any country worldwide. 

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The FDA’s Updated Monkeypox Response

Since the beginning of the monkeypox outbreak, the FDA has had a robust response. Working with the Center for Disease Control (CDC), they increased the production and distribution of the FDA-cleared CDC non-variola orthopoxvirus test. The FDA also engaged commercial developers in creating molecular diagnostic tests and rapid molecular or antigen tests, in addition to other tests. 

The most recent guidance released reinforces these efforts. The guidance outlines that FDA intends to prioritize the Emergency Use Authorization (EUA) for high-throughput diagnostic tests, tests with home specimen collection, or rapid diagnostic tests created by experienced developers.

The guidance describes voluntary templates on how developers could validate a test or when an EUA request. These templates include the submission of preliminary information to the FDA. This information includes a description of the test technology, manufacturing capacity, ramp-up time frames, test throughput, the expected timeline for development, validation, submission of an EUA request, and any available validation data.

However, the guidelines clearly state that these templates are recommendations, not requirements. In addition, the FDA does not intend to enforce requirements for certain tests developed by laboratories that are used without submitting an EUA request. However, these tests need appropriate validation in these instances, and the laboratories must notify the FDA within 30 days of use.

On the guidelines, Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said, “The policy announced today is intended to support the development of more validated monkeypox tests and expand access to testing.

These FDA testing guidelines come the same day that the U.S. surpassed 20,000 monkeypox cases.

20,000 Monkeypox Cases, Yet Growth Slows

Monkeypox cases surpassed 20,000, the most in any country in the world. According to the CDC, that number increased to 21,504 as of 5:00 PM EDT on September 8. Worldwide, there are around 56,609 cases at the time of writing.

However, according to a report from the CDC, case growth is slowing in the U.S. Reaching a daily average peak around Mid August, the amount of daily new cases has declined since. 

With continued efforts and new FDA testing guidelines, daily new cases will likely continue their fall throughout the latter half of the year. 

Author

Max Heirich