Emergency Use Authorization Issued by FDA for Mpox Virus DNA Test
Last Friday, the FDA issued an emergency use authorization (EUA) for the Cepheid Xpert Mpox test for use in a point-of-care setting.
In a statement on their website, the regulatory body announced that validation data had been gathered through the National Institutes of Health (NIH) Independent Test Assessment Program, established as a collaboration between the FDA and the NIH.
Cepheid’s Xpert Mpox test is a real-time polymerase chain reaction (PCR) assay which tests mpox virus DNA in swab specimens.
The move comes in response to a rising awareness of the issues potentially posed by a broader mpox outbreak in the United States.
EUAs exist under FDA regulation to improve the availability of medical countermeasures — such as vaccines — during public health emergencies.
The framework helps to accelerate the provision of unapproved medical products in emergency scenarios such as pandemics where no adequate and approved alternatives are available.
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One recent example of an emergency use authorization would include the COVID-19 pandemic, for which the FDA has issued multiple EUAs for different drugs subject to their efficacy against different variants of the virus.
The FDA announced last August that the mpox virus had “a significant potential to affect… national security or the health and security of United States citizens living abroad.”
Guidance on the disease from the EMA states that mpox virus DNA is similar to smallpox in its lineage, but less severe.
The EMA’s Emergency Task Force (ETC) is looking at available treatment options and other measures to combat the mpox outbreak, including facilitating clinical trials and working with EU partners.
Cepheid specialise in PCR testing approaches and diagnostics; Cepheid’s Xpert Mpox test can be used to test human lesion swab specimens obtained from individuals suspected of having mpox.
Following the disruption caused by the COVID-19 pandemic, healthcare regulators and bodies across the world are keenly following subsequent disease outbreaks.
With the threat of a future pandemic still a tangible possibility, further EUAs for other PCR tests and vaccines are all but certain.
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