NEW YORK – The US Food and Drug Administration on Tuesday expanded its library of guidance for monkeypox test developers by releasing two templates for development of antigen tests for monkeypox infection, following the publication earlier this year of a pair of templates for molecular test development.
The new documents are a summary template and a more in-depth template, both of which provide the FDA's current recommendations concerning data and other information diagnostic developers should submit to the agency in support of an Emergency Use Authorization (EUA) request or pre-EUA request for a monkeypox virus or orthopoxvirus antigen diagnostic test. The guidance includes descriptions of the testing needed to ensure analytical and clinical validity and appropriate comparators.
"The templates are intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used," the agency said in an announcement.
The documents also recommend that tests developers interested in pursuing an EUA send preliminary information to the FDA and check for test validation opportunities through the National Institutes of Health Rapid Acceleration of Diagnostics Independent Test Assessment Program.
Agency officials said during a virtual townhall meeting in September they had been working on a template for antigen test development despite uncertainty whether rapid antigen tests were sensitive enough to detect monkeypox infections. The agency representatives on the call said they also saw potential for over-the-counter molecular assays to bridge gaps between high-sensitivity molecular tests and lower-cost rapid antigen tests.
FDA officials provided similar guidance in 2021 for developers of SARS-CoV-2 antibody tests.