How to get the Inside Track for Your Monkeypox EUA

Similar to what was done with COVID-19, the National Institute for Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative has established a Monkeypox Independent Test Assessment Program (ITAP) and it currently accepting new proposals on a rolling basis to address the outbreak.  The program began accepting proposals on September 7, 2022, from manufacturers that have existing technologies and can scale production, while meeting FDA quality requirements.

The focus of the program is for both molecular and antigen tests that can be used in either point-of-care settings or home use. The program is currently not accepting applications for antibody tests (HPM has blogged previously about FDA’s Monkeypox Policy here).  The program provides support to manufacturers by providing both analytical and clinical testing that meets FDA requirements for an EUA submission.

Manufacturers can apply if they meet the following criteria:

• Demonstrated capacity for manufacturing and distributing high-quality in vitro diagnostics, AND at least one of the following:
  • An existing technology adapted for POC or home detection of monkeypox virus, at design lock, with performance data
  • An existing monkeypox virus test kit available for POC or home diagnostic use in international markets
  • A self-collection kit for monkeypox virus samples which can be modified and optimized for at-home use

Getting accepted into the ITAP program may be your best bet in getting a subsequent EUA for your Monkeypox test, because (as of right now) there is only one cleared comparator to use for your clinical testing, CDC’s non-variola orthopoxvirus test.  It may be difficult to set up a clinical study on your own as use of the CDC’s assay is limited to Laboratory Response Network (LRN) designated laboratories. In addition, the ITAP program provides the manufacturer an entire project team and necessary resources to ensure the analytical testing is completed quickly and meets FDA requirements.

In addition to filling out the application for the ITAP program, manufacturers will still need to submit their intent to file an EUA with the FDA within 30 days of the FDA Monkeypox policy being announced in the Federal Register.  This means you should complete both your ITAP submission and your intent to submit an EUA to the FDA now — or you may miss being considered for priority review.