Cepheid Supports the International Mpox Emergency Declared August 2024

Mpox Emergency Declared August 2024
 

On August 14^th, 2024, the World Health Organization (WHO) declared a public health emergency of international concern (PHEIC) due to a recent upsurge of mpox, warning that a new clade of the virus was spreading at an alarming rate.¹ This year, more than 17,000 cases and 500 deaths have been reported, mainly among children in the Democratic Republic of Congo (DRC).^2.

A New Virulent Version of mpox 

In 2023, a new strain of the virus causing mpox, clade Ib, emerged in the DRC.¹ The rapid spread of clade 1 has resulted in a 160% increase in the number of reported mpox cases in 2024 compared to 2023². Clade I also causes a higher percentage of people with mpox to get severely sick or die compared to clade II.^2,5 This increase in virulence is contributing to international concern.

This outbreak is impacting different populations than the 2022 one, with higher heterosexual transmission, especially among female sex workers driving the current outbreak, and a much higher prevalence in children than seen with the clade II outbreak.² The new mechanisms of transmission are not yet fully understood.

Clade I mpox has spread from the DRC to neighboring countries, including Burundi, Central African Republic, Republic of the Congo, Rwanda, Uganda, and Kenya.⁵ The declaration of a PHEIC acknowledges the potential of this new mpox virus to spread further across countries in Africa and possibly outside the continent. 

What is Needed to Contain the Disease and Prevent Further Spread?
 

Significant community and global efforts are needed to curb mpox and prevent the global spread that was seen in 2022. The Director General of the African Centres for Disease Control and Prevention, Dr. Jean Kaseya, recently declared in a public statement, “This is not just another challenge; it is a crisis that demands our collective action, a moment that calls upon the very essence of our humanity, our unity, and our strength,” in a call for solidarity and swift action.⁶    

WHO is working with countries, manufacturers, and partners including the interim Medical Countermeasures Network to facilitate equitable access to vaccines, therapeutics, diagnostics, and other tools.¹  

The Role of Diagnostics

The Foundation for Innovative New Diagnostics (FIND) has highlighted the pressing need to accelerate the development and assessment of rapid molecular tests that can detect both clades I and II in primary and community care settings.⁷ “The mpox emergency shows us how important it is to have quick and accurate diagnosis at the primary care level to support the communities most affected,” noted Sergio Carmona, Chief Medical Officer at FIND.⁷

Detection of viral DNA by polymerase chain reaction (PCR) is the preferred laboratory test for mpox with the best specimens taken directly from swabbing the rash.⁸

Near-patient, Lab-quality Tests
 

Cepheid is closely tracking the mpox outbreak in Africa and taking steps to ensure quality diagnostic tests are available to help address the recent international health emergency. 

Cepheid supports the international community in responding to the mpox health emergency. This commitment to enabling access to diagnostic tests to impact global health is part of Cepheid’s ongoing legacy, which includes responding to the 2022 mpox crisis with a point-of care diagnostic test for mpox. 

“Laboratory-quality PCR-based tests that can be performed in decentralized settings and provide results on the same day of the visit best support clinical management and public health response to the mpox outbreak,” said Jennifer Rakeman-Cagno, Cepheid's Senior Director of Scientific Affairs and Public Health Programs. 

Access to quality testing with results returned in the same visit enables providers to treat patients appropriately, enables patients to make informed decisions about their health and to keep others around them healthy, and enables public health authorities to track the spread of the virus and initiate appropriate mitigation measures.

Cepheid’s Xpert® Mpox test is one of only two point-of-care PCR tests granted Emergency Use Authorization by the U.S. FDA in 2023. The Xpert Mpox swab-based test takes 36 minutes and calls out two targets: clade II-specific mpox and non-variola orthopoxviruses in general. 

Rakeman-Cagno explained that "in an outbreak, the non-variola orthopoxvirus result can be determined in the context of the local epidemiology as diagnostic for clade I.”   In an outbreak scenario where clade I mpox is spreading and other non-variola orthopoxviruses that may cause similar symptoms are not spreading, the detection of non-variola orthopoxvirus DNA from a lesion swab may be enough to provide diagnostic information to patients and providers, and public health data to health authorities. 

The Xpert Mpox test runs on Cepheid’s GeneXpert system which has over 55,000 installations worldwide, including in high-burden developing countries.  

Cepheid has been increasing manufacturing to make tests available where they are needed. Rakeman-Cagno continued, “To best address the need for access to PCR-based diagnostics in response to the outbreak, Cepheid has been prioritizing orders as best we can to meet the needs across the globe."

Learn more about the Xpert Mpox test and FAQ here.

Xpert Mpox Emergency Use Authorization Status:
 

This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by the authorized laboratories; This product has been authorized only for the detection of nucleic acid from monkeypox virus or other non-variola orthopoxviruses, not for any other viruses or pathogens; and the emergency use of this product is only authorized for the duration of the declaration 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, under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.