Mpox: the role of FIND

On 14th August 2024, WHO declared mpox as a public health emergency of international concern (PHEIC). Three days later, we established an internal mpox response taskforce.

This taskforce focuses on several key areas, from scouting innovative diagnostic tools and evaluating their efficacy to ensuring regulatory pathways exist and forecasting demand. As part of our immediate response to the current outbreak, we have also completed an initial diagnostic demand modelling and commenced site activation activities for analytical and clinical evaluations.

Mpox diagnostic landscape

As mpox continues to gain ground and threaten the lives of millions of people, we have been updating the technology landscape, which is publicly available through our test directory. This resource provides comprehensive information on mpox molecular and antigen-based diagnostics, including manufactures, test types, test formats, performance, evidence, and regulatory approvals.

Selection of promising mpox point-of-care (POC) diagnostic tests for FIND independent evaluation

FIND has recently issued and closed a request for proposals to seek developers and manufacturers of mpox diagnostics to participate in a performance evaluation in low- and middle-income countries and accelerate product development.

Methodology

• Application dossiers were reviewed internally by FIND based on the material provided by the applicants
• First screening of applications was based on eligibility criteria including technology readiness level (TRL7 or above) and suitability for decentralized testing
• Commercially available tests (regulatory approved/authorized or research use only) were prioritized for a tier-1 review, focusing on both technical and business criteria
  • More than 20 technical assessment criteria including analytical/clinical evidence
  • 9 business assessment criteria including distribution capacity/presence in DRC and neighbouring countries and cost/price consideration

What could mpox testing look like in the next 120 days?

We’ve estimated how many people might need testing for mpox in the coming 120 days (October through December) in priority countries. Depending on how the outbreak develops, the number of people needing tests could range from as few as 1,261 to as many as 845,740 across the DRC, Burundi, CAR, Nigeria, Uganda, Kenya, Rwanda, Republic of Congo.

We’ve shared these estimates with the WHO and Africa CDC, and we’ll continue to work closely with them and other partners to update the numbers. This will guide testing plans, procurement, and targets as the situation evolves.

FIND external collaborations on mpox response

FIND continues to support the continental and global mpox response with partners. For example, FIND provides insights into the International Pandemic Preparedness Secretariat’s mpox updates towards the 100 Days Mission goal, which aims to provide key medical countermeasures once a public health emergency of internation concern is declared.

In addition, FIND is a key partner on mpox diagnostics to Africa CDC as part of the continental response plan and participates and co-chairs the WHO Mpox Diagnostic Operational Group.

At FIND, we are committed to ensuring diagnostics reach the areas where they are most needed. We are working towards equitable access, gender-sensitive approaches, and building sustainable supply chains. These efforts will help lay the groundwork for a stronger and more resilient global health system.

Supporting the 100 Day Mission through FIND mpox response initiatives

As part of the 100 Day Mission, FIND mpox response initiatives are strategically designed to ensure the rapid availability of diagnostics within the first 100 days of a Public Health Emergency of International Concern (PHEIC).

Our work focuses on identifying and validating mpox diagnostics, with a particular emphasis on tests that can detect the new clade 1b. Through the evaluation of 10 promising diagnostics across 4 key sites, we aim to accelerate the development and deployment of effective diagnostic tools for outbreak response.

In line with the Diagnostics for Outbreaks and Disasters (DxOD) framework, FIND has established a dedicated mpox taskforce that coordinates weekly to ensure all stakeholders are aligned and efforts are cohesive.

FIND aims to generate evidence to support regulatory approvals and facilitate technology transfer for local manufacturing; FIND also aims to help build regional capacity for diagnostic production in affected regions.

Additionally, real-time surveillance and data-sharing mechanisms will be integrated into our approach, providing the timely insights needed for informed decision-making. These coordinated efforts will be central to achieving the 100 Day Mission’s goal of equipping the world with the diagnostics necessary to control outbreaks quickly and effectively.