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September 23, 2022 - Healthcare, FDA, Regulatory, Medical Devices + Diagnostics, United States

New Opportunities for Test Developers: Monkeypox Diagnostics

Life Science

For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products. However, test developers must act fast. The Food and Drug Administration is asking for notifications of intent to develop monkeypox diagnostic tests by October 13, 2022. 

On August 4, 2022, HHS Secretary Becerra declared a Public Health Emergency acknowledging the ongoing rapid transmission of monkeypox and the necessity of an urgent response. In a public health emergency, FDA requires in vitro diagnostic tests, including laboratory developed tests, to undergo premarket review to ensure the accuracy and reliability of such testing. To speed the availability of these tests, FDA has unique authorities during an emergency to issue emergency use authorizations (“EUAs”) under an expedited review process created by section 564 of the Federal Food, Drug, and Cosmetic Act. On September 7, 2022, Secretary Becerra signed a section 564 Declaration allowing FDA to use its EUA authority for in vitro diagnostics to more rapidly expand testing availability.

To aid developers in preparing EUA submissions, on September 13th FDA issued a final guidance: Policy for Monkeypox Tests to Address the Public Health EmergencyAs noted in the guidance, “FDA intends to prioritize review of EUA requests for high-throughput diagnostic tests, tests with home specimen collection, or rapid all from experienced developers with high manufacturing capacity.” Significantly, FDA requested interested parties send an intent to submit an EUA by October 13, 2022. It should be noted that FDA does not expect EUA requests for certain validated diagnostic LDTs that are developed and performed in a single lab, that uses PCR, and when the only sample type is a lesion swab sample from a potential monkeypox lesion.

FDA also issued an EUA template and summary template for molecular diagnostic tests, which are available for download on Monkeypox Emergency Use Authorizations for Medical Devices. For general FAQs and regular updates, FDA is maintaining a Frequently Asked Questions page available here: FAQs on Testing for Monkeypox.

Since issuing the declaration, FDA has issued one emergency use authorization for a multiple target, Real-Time PCR test. This test is joined on the market by the CDC-developed, FDA-cleared non-variola Orthopoxvirus (“NVO”) assay. FDA has further clarified that there are no current shortages of monkeypox tests, test kits, nor reagents, especially the CDC NVO assay.

In addition, leadership from FDA’s CDRH Diagnostics Office (OHT7) will now host a weekly virtual town hall for monkeypox test developers beginning September 21, 2022 (12:05 - 1:00 p.m. ET). The webinar, in a similar format to the virtual town hall for COVID-19 test developers, will include announcing updates, addressing previously emailed questions, and answering live questions. Now that the town hall for COVID-19 test developers occurs on a monthly basis, there will be a monthly combined town hall addressing both COVID-19 and monkeypox updates and questions beginning on September 28, 2022 (12:05 - 1:00 p.m. ET). For monkeypox virtual town hall details, please visit the Virtual Town Hall Series - Monkeypox Test Development and Validation.

MoFo’s FDA + Healthcare Regulatory and Compliance practice is following these developments closely and assisting developers in the preparation of their notifications and submissions. We look forward to assisting test developers as they respond to this unfolding public health emergency.