Pathways' Pick of the Week: FDA Shifts Infectious Disease Priorities

A revision to FDA’s emergency COVID-19 test guidance is under White House review and expected out soon. The original version of the guidance was one of the first COVID-19 response guides issued by FDA in March 20 and it has been updated multiple times (most recently last November) as the agency’s COVID test policies have evolved.  It’s possible this latest revision will further deprioritize review of emergency user authorization submissions for some test categories at this state of the pandemic and as FDA’s diagnostics office needs to shift resources to the more recent public health emergency of monkeypox.    

 On September 7, about a month after HHS declared monkeypox a public health emergency, it officially opened the legal channel to grant EUAs for monkeypox diagnostics. On the same day, FDA granted its first monkeypox EUA—a molecular test from Quest Diagnostics. In parallel, the agency issued an immediately-in-effect guidance outlining its EUA policies for monkeypox tests. It also issued a template to standardize the EUA submissions, a strategy it initiated during the COVID-19 pandemic. The guidance also reflects some lessons-learned from COVID. Notably it allows lab-developed tests from high-complexity labs to offer testing without an EUA as long as it notifies FDA that is has validated the assay. The agency was criticized for slowing access to COVID-19 tests by requiring EUAs for LDTs. Packaged IVD test kits for monkeypox, however, will require an EUA. The guidance also specifies that certain types of modification to available tests will not require a new EUA.

Image from Wikimedia Commons (CC BY2.0)

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