The global community must galvanize action to address the challenge of using 19th century diagnostics to guide 21st century programmes for neglected tropical diseases (NTDs). It is inconceivable that, in 2021, basic tools such as microscopes for routine diagnosis of NTDs are lacking. The COVID-19 pandemic has demonstrated that support, determination and mobilization of resources can stimulate the development of new diagnostics in record time.
These are some of the key messages that emerged from discussions during a WHO webinar on diagnostic needs for NTDs held on 28 October 2021.
Field experiences were shared about the need for sensitive, specific point-of-care tools to detect NTDs. The ease-of-use of these tools in responding to field-based needs is crucial for thousands of field workers and volunteers who continue to support implementation of NTD programmes.
Diagnostic tools that are suitable for use in low-transmission areas are needed to accelerate the elimination of Asian schistosomiasis in several countries of WHO’s Western Pacific region. As developing new tools take a long time, the region is considering optimizing the use of existing tools. It also plans a South-South partnership to strengthen national laboratory capacity.
The webinar also discussed new testing techniques that are being used in remote communities and the possibility of integrating diagnostics for multiple NTDs into single platforms in settings where country capacity exists. Brazil, for example, is making progress in providing access to diagnostics for NTDs by encouraging investments for research and development, and in producing and commercializing laboratory techniques developed by national institutions. Furthermore, regulation for diagnostics should be increasingly harmonized, and WHO can help in supporting the training of regulators.
Other points raised during the webinar included the necessity for the right partnerships to develop quality-assured diagnostics based on needs and targets of the new road map. While target product profiles can help to define the right diagnostics, access to trial sites and clinical samples are critical.
The webinar also considered coordinated, systematic efforts to address diagnostic needs, as countries start to integrate new tools into their national surveillance systems and implement road map strategies. From a donors’ perspective, WHO’s Diagnostic and Technical Advisory Group is a concrete step towards developing new tools for several diseases. Its first task was to identify priority needs after a landscape analysis of diagnostics. Substantial progress has been made since 2019: about 19 target product profiles have been developed through an extensive consultative process, of which eight have been published. Such progress has boosted donors’ confidence in supporting the development of new diagnostic tools.
Although some strict regulatory requirements (such as the In Vitro Diagnostic Medical Devices Regulation) can slow efforts to develop NTD diagnostics, donors, manufacturers and researchers should work closely to create the tools needed to achieve the road map targets by 2030.