The U.S. Food and Drug Administration (FDA) says it is taking steps to further increase monkeypox testing capacity and accessibility nationwide as part of its continued commitment to addressing the ongoing outbreak.

“Since the beginning of the monkeypox outbreak, the agency has used the full breadth of its authorities to work quickly and proactively to ensure the availability of medical countermeasures, including diagnostics, to prevent the spread of the disease,” says FDA Commissioner Robert M. Califf, MD. “We will continue to engage federal public health partners like the Centers for Disease Control and Prevention, laboratories, commercial manufacturers, health care professionals, and consumers to facilitate the availability of monkeypox tests to people and communities who need them.”

Since monkeypox was first detected in the U.S., the FDA has been:

  • working with the CDC to increase production and distribution of the FDA-cleared CDC non-variola orthopoxvirus test;
  • clearing the use of additional reagents and automation to increase the testing capacity of laboratories using the CDC test;
  • proactively engaging with commercial manufacturers on the development and validation of both lab-based molecular diagnostic tests and rapid molecular or antigen tests for use at the point-of-care (such as clinics) or at home;
  • facilitating the development and availability of test components to help high-complexity CLIA-certified laboratories develop tests for monkeypox; and
  • monitoring tests that have been developed and used since the start of the outbreak. For example, on July 15, the FDA issued a safety communication recommending the use of lesion swabs to avoid false results.

New Guidance to Facilitate Development of Additional Testing

The FDA issued guidance that outlines the agency’s current thinking regarding enforcement policies, recommendations for emergency use authorization (EUA) requests for monkeypox diagnostic tests, and the FDA’s plans to prioritize review of EUA requests.

The agency is also providing voluntary templates that test developers may use when validating a test or when submitting an EUA request. These templates include recommendations—not requirements—for how a developer could validate a test to help ensure it is appropriately accurate and reliable. The FDA intends to update its recommendations, as needed, in response to the developing emergency. 

This guidance follows a declaration by the Secretary of the Department of Health and Human Services justifying the emergency use of in vitro diagnostics for detection and/or diagnosis of the monkeypox virus or non-variola orthopoxviruses. Under the declaration, the FDA may issue an EUA to allow the use of unapproved in vitro diagnostics or unapproved uses of approved in vitro diagnostics.

“Today’s important actions further aid the monkeypox response by working toward expanding vital testing capacity and facilitating the detection of cases nationwide in an effort to stem the spread of the virus,” says Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “The policy announced today is intended to support the development of more validated monkeypox tests and expand access to testing.”

As explained in the guidance, the FDA does not intend to enforce requirements for certain tests developed by laboratories that are used without submission of an EUA request where they are appropriately validated and the laboratories notify the FDA within 30 days, among other things.

The agency’s intent is to facilitate the development of additional tests to address local availability and accessibility concerns not addressed by current testing capabilities. The FDA will monitor the situation and may adjust its policies as appropriate to address testing needs. The FDA also may decide, on a case-by-case basis, not to object to individual labs offering tests using different specimen types or technologies to address patient care needs.

Commercial manufacturers who intend to make a diagnostic test for monkeypox and want to seek authorization through the more streamlined EUA process should inform the FDA of their plans within 30 days, as well.

It is important that all tests be appropriately validated prior to use, as false results can have a negative impact on both the individual patient and the public health broadly. Currently, only lesion swabs have been shown to be an appropriate specimen type for diagnosing monkeypox. If and when other specimen types are validated, the FDA will inform the developer community and the public. Test developers are encouraged to discuss alternative specimen types, technologies, and approaches to validating their test with the agency.

FDA Authorizes Quest Diagnostics Monkeypox Virus Real-Time PCR Test

In addition to the FDA’s guidance, the agency issued the first EUA for a monkeypox in vitro diagnostic. The Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR is intended to detect monkeypox and other non-variola orthopoxvirus DNA using lesion swab specimens. Quest Diagnostics submitted data demonstrating that its test for distribution to other laboratories met the standards for issuance of an EUA.