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FDA to Issue EUA for Monkeypox Tests

by | Sep 14, 2022 | News, Open Content

The agency will also allow CLIA labs to use serology and antigen tests without EUA.

It’s déjà vu all over again. The federal government’s new strategy for expanding access to lab tests for monkeypox is eerily reminiscent of its initial response to the COVID-19 public health emergency, warts and all.

Last week, the U.S. Department of Health & Human Services (HHS) took a page out of the COVID playbook by announcing that it was exercising its authority under section 564 of the Food, Drug, and Cosmetic Act to allow the FDA to provide Emergency Use Authorization (EUA) clearance for monkeypox tests. Hundreds of new COVID-19 test products reached the US market via the EUA pipeline during the coronavirus pandemic. Under section 564, the FDA may issue EUA for a monkey pox in vitro test product if it determines that, among other things:

  • The product may be effective in diagnosing, treating, or preventing the emergency disease or condition;
  • The known and potential benefits of the product outweigh its known and potential risks; and
  • There’s currently no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition.

The same day of the HHS announcement, Sept. 7, the FDA issued guidance outlining how it intends to exercise its new authority. First priority for EUA review will go to submissions from “experienced developers with high manufacturing capacity” for high-throughput tests where samples can be collected at home, and rapid antigen tests.

As it did with COVID-19, the FDA also said it wouldn’t enforce certain federal regulatory requirements for laboratory developed tests for monkeypox used without EUA, provided that tests are “appropriately validated” and that the labs notify the FDA of their use within 30 days of making the product available.

This same market-now-and-get-permission-later approach resulted in dozens of dubious COVID-19 serology antibody tests reaching the market, forcing the agency to crack down. The FDA would later acknowledge that the policy was flawed and promised not to repeat the mistake when responding to future emergencies.

The monkeypox policy is not exactly the same, the FDA insists. This time, the agency says it won’t object to use of monkeypox antibody tests developed and performed by CLIA-certified labs operating under academic medical centers, as long as test results are used alongside other diagnostics for direct medical care of the patient. 

“This should mitigate the potential misuse of monkeypox serology test results while also fostering research from availability of data from serology testing of patients,” the FDA stated.

We shall see.

See a more in-depth version of this article in the October 2022 issue of National Lab Reporter, in advance of digital PDF publication.