On September 7, the Food and Drug Administration declared a public emergency requiring clinical laboratory tests for monkeypox to obtain emergency use authorization (EUA) before offering the test clinically. To assist developers in the EUA submission process, the FDA published guidance for monkeypox tests to address the ongoing public health emergency. The guidance describes the FDA’s review priorities for requests for monkeypox tests and what laboratories need to do when developing tests to diagnose the disease. Moreover, the guidance document states that laboratory-developed tests (LDTs) are not required to submit an EUA if these laboratories notify the FDA. The CAP is engaged with the FDA on the new guidance and urges the agency to ensure it takes the necessary steps so laboratories can expeditiously offer and test patients for monkeypox.

What the FDA’s Emergency Declaration on Monkeypox Means for Laboratories

At this time, a CLIA-certified laboratory may develop and perform monkeypox tests that meets the requirements to perform tests of high complexity where:

• The test uses molecular PCR technology;
• The test uses lesion swabs;
• The test has been appropriately validated; and,
• The laboratory notifies the FDA of validation within five business days of offering the test (or, for currently-offered tests within this scope, notifies the FDA within five business days from the date of the guidance) that it has appropriately validated such test (by email to MPXDx@fda.hhs.gov with a subject line “FDA Notification of Development and Validation of Monkeypox Test”).

The policy does not apply to laboratory-developed tests (LDTs) with home specimen collection or at-home tests or tests using specimen types other than lesion swabs or technologies other than PCR. However, on a case-by-case basis, the FDA would consider if academic medical centers can offer such tests using a different specimen type or a different technology for laboratories directly involved in patient care.