Landscape analysis of commercially available and pipeline in vitro diagnostics for fungal priority pathogens

Overview

This report presents the first World Health Organization (WHO) analysis of commercially available diagnostic products and pipeline diagnostic products for invasive fungal diseases (IFDs) caused by WHO Fungal Priority Pathogens and on the identifiable gaps. Because resistance to antifungal medicines is a growing public health threat, the report also focuses on in vitro diagnostics (IVDs) that can play a role in limiting and identifying antimicrobial resistance (AMR).

IFDs pose a growing global health threat, especially for immunocompromised individuals. It is estimated that there are more than 6.5 million invasive fungal infections and 3.8 million deaths globally each year associated with IFDs. Antifungal resistance is a rising concern. In response, the WHO established its first Fungal Priority Pathogens list in 2022 to prioritize research and development in this area.   

The development of products to diagnose IFDs and to ascertain their susceptibility to antifungal agents has generally lagged behind advances made in other areas, including diagnostic products for priority bacterial infections. Furthermore, access to diagnostics for IFDs is unevenly distributed, particularly in low- and middle-income countries (LMICs), leading to undiagnosed cases and potential overuse of antifungal treatments. WHO has undertaken this report to:

(i) map available and pipeline diagnostic products for the detection and identification of IFDs, as well as for the detection of susceptibility/resistance to invasive fungal pathogens; 

(ii) identify gaps in the availability of such diagnostics, with an emphasis on LMICs; and

(iii) establish research and development (R&D) priorities that could help meet the identified gaps and needs in these diagnostics products.

This report is part of the WHO's ongoing efforts to prioritize and coordinate global R&D efforts to support the development and optimization of new diagnostics and platforms to tackle drug-resistant infections.