Global health security is an ever-present concern. Pandemics caused by emerging and re-emerging infectious diseases put lives, health and prosperity at risk.
While outbreaks are often unpredictable, this is not always the case; Lassa fever, for example, appears every year in Nigeria, but few regulatory-approved diagnostics – and no vaccines or medicines – are available.
Diagnostics are fundamental to the identification, containment and eventual resolution of disease outbreaks. Poor diagnostic capacity compromises outbreak detection and response, both at a national level and in community healthcare settings. In the case of the 2013–16 Ebola epidemic in West Africa, it took 3 months to figure out that the infection was indeed Ebola. That delay resulted in the loss of thousands of lives and billions of dollars in the cost of response.
WHO has developed an R&D Blueprint for a shortlist of high-priority pathogens that could spark a major international public health emergency – including Disease X, as a reminder that the next outbreak may be caused by a pathogen we know very little about today, let alone have diagnostics, vaccines or treatments in development for it.
Six of the 10 Blueprint pathogens have major unmet diagnostic needs, and while each pathogen presents specific challenges, several common themes negatively impact all outbreak situations. These include fragmented and unreliable funding pathways, limited access to specimens and reagents for accelerated R&D, inadequate capacity for clinical evaluation of new diagnostics, and lack of incentives for companies to develop and manufacture diagnostics for priority pathogens during non-outbreak periods.
Outbreak preparedness has historically centred on vaccine needs. This focus must expand to include diagnostics, as they are imperative for enabling rapid vaccine development – to inform epidemiological understanding and create well-targeted vaccination efforts and to improve surveillance that allows rapid vaccination response.
Together with our partners and donors, we are working to strengthen diagnostic preparedness for the Blueprint pathogens, as well as dengue fever, cholera, yellow fever, and bacterial meningitis. Activities are organized across three areas.
- Identifying technical solutions that will close R&D gaps, including diagnostic platforms that can support tests for multiple pathogens, with enhanced connectivity to enable swift identification of an outbreak.
- Improving outbreak response speed by ensuring readiness to conduct robust clinical trials at short notice, supported by regulatory pathways that can expedite approval of successful diagnostic candidates.
- Supporting market sustainability by exploring innovative new financing solutions, procurement and supply mechanisms, for ongoing affordability and availability of critical diagnostics.
We are also working closely with the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance to assess opportunities for integrating diagnostics into existing mechanisms for vaccine development and deployment in response to disease outbreaks.
Pandemic Preparedness R&D pipeline
|Catalyse Development||Guide Use and Policy|
|WHO R&D Blueprint pathogen landscaping||Semi-open molecular platform for Lassa (Altona, Cepheid)||Lassa RealStar 2.0 ERPD for WHO (Altona)|
|UTI landscaping & project definition||POC multi-analyte, polyvalent (Blink Dx)|
|Substandard & falsified medicine screening||Yellow fever rapid test (Mologic/IPD)|
Download our full R&D pipeline.