# 2026-15964: FDA Greenlights Mpox Test Detecting Herpes Too in Outbreak

2026-15964, Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-08-06, effective 2026-07-09; PRIA reads it as touching household money (as of 2026-08-13).

- Canonical: https://policyrisk.com/federal-register/2026-15964
- As of: 2026-08-13
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-15964
- Title: Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 50848
- Published: 2026-08-06
- Effective: 2026-07-09
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-08-13

## In one line

FDA Greenlights Mpox Test Detecting Herpes Too in Outbreak

## Summary

The Food and Drug Administration (FDA or Agency) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in response to an outbreak of Mpox. FDA has issued an Authorization for an in vitro diagnostic device, Allplex HSV-1&2/VZV/ MPXV Assay, for the simultaneous qualitative detection and differentiation of viral nucleic acid from monkeypox virus (MPXV clade I/II and MPXV clade II)1, herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2), and varicella-zoster virus (VZV). The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the August 9, 2022, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves monkeypox virus. On the basis of such determination, the Secretary of HHS declared, on September 7, 2022, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to the FD&C Act, subject to terms of any authorization issued under that section. The Authorization, which includes an explanation of the reasons for issuance, is listed in this document, and can be accessed on FDA's website from the link indicated.

## Effects PRIA read

- EUA Issued for Multiplex Mpox Diagnostic: benefit, low. On July 9, 2026, the FDA issued an Emergency Use Authorization (EUA) for the Allplex HSV-1&2/VZV/MPXV Assay. The authorized test can simultaneously detect and differentiate monkeypox virus (MPXV clade I/II and MPXV clade II), herpes simplex virus 1 and 2 (HSV-1, HSV-2), and varicella-zoster virus (…

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## Sources
- [2026-15964 on federalregister.gov](https://www.federalregister.gov/documents/2026/08/06/2026-15964/authorization-of-emergency-use-of-an-in-vitro-diagnostic-device-in-response-to-an-outbreak-of-mpox)
- [2026-15964 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-08-06/pdf/2026-15964.pdf)

## Related
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- [Next: 2026-15965, Information Collection Request to Office of Management and Budget; OMB Control…](https://policyrisk.com/federal-register/2026-15965)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-15964 (as of 2026-08-13).