What Does This Mean?

Monkeypox virus is a zoonotic infection, caused by Orthopoxvirus genus of the Poxviridae family like variola virus (the causative agent of smallpox) and can spread among humans. Cases of Monkeypox have been reported from countries, including the United States. On July 23, 2022, the World Health Organization (WHO) declared the global outbreak of Monkeypox a Public Health Emergency of International Concern (PHEIC).

On September 7, 2022 and following the declaration of Monkeypox as a public emergence in the US, the Secretary of HHS declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics (IVDs) for detection and/or diagnosis of Monkeypox virus. This means that at the current state of the emergency to mount an effective response to the outbreak, rapid detection of cases and contacts, is a priority for the clinical management and infection control, and implementation of community mitigation efforts are critical.

The FDA is the agency responsible for authorizing Monkeypox IVDs. The FDA published information for IVD developers including policies and guidance for the development and authorization of Monkeypox IVDs which are detailed and extremely helpful available at: Policy for Monkeypox Tests to Address the Public Health Emergency Monkeypox Emergency Use Authorizations for Medical Devices (including EUA templates).

Under this declaration, the FDA Commissioner may allow unapproved IVDs or unapproved uses of approved IVDs to be used during the declared emergency. Currently there is an FDA cleared IVD for non-variola orthopoxvirus (developed by CDC) and is used in the current emergency. However, it is not enough to substantiate the needs of the emergency. 

Who Is Affected?

IVD developers of new tests or new indications for existing IVDs. The IVD developers include Single site laboratories that are certified under CLIA and meet the requirements to perform tests of high complexity. The goal of the FDA guidance is to expand available testing capabilities in healthcare settings, reference laboratories, and commercial laboratories.

How Can We Help?

Veranex has deep institutional knowledge of the EUA process and extensive experience from the COVID-19 pandemic and is deeply equipped to aid innovators along the Monkeypox EUA process.

4 Lessons Learned

What Did We Learn from the COVID Emergency Use Authorization that We Can Apply to Monkeypox?

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