02853nas a2200253   4500000000100000008004100001260003700042653002400079653005700103100001200160700001300172700001400185700001200199700001500211700001400226700001600240700001700256245011800273856009900391300001300490490000700503520207500510022001402585       2022                            d  bPublic Library of Science (PLoS)10aInfectious Diseases10aPublic Health, Environmental and Occupational Health1 aChoi HL1 aDucker C1 aBraniff S1 aArgaw D1 aSolomon AW1 aBorisch B1 aMubangizi D1 aAinsworth SR00aLandscape analysis of NTD diagnostics and considerations on the development of a strategy for regulatory pathways  uhttps://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0010597&type=printable  ae00105970 v163 a<p>Access to quality-assured, accurate diagnostics is critical to ensure that the 2021–2030 neglected tropical disease (NTD) road map targets can be achieved. Currently, however, there is limited regulatory oversight and few quality assurance mechanisms for NTD diagnostic tools. In attempting to address such challenges and the changing environment in regulatory requirements for diagnostics, a landscape analysis was conducted, to better understand the availability of NTD diagnostics and inform future regulatory frameworks. The list of commercially available diagnostics was compiled from various sources, including WHO guidance, national guidelines for case detection and management, diagnostic target product profiles and the published literature. The inventory was analyzed according to diagnostic type, intended use, regulatory status, and risk classification. To estimate the global need and size of the market for each type of diagnostic, annual procurement data were collected from WHO, procurement agencies, NGOs and international organizations, where available and global disease prevalence. Expert interviews were also conducted to ensure a better understanding of how diagnostics are procured and used. Of 125 diagnostic tools included in this analysis, rapid diagnostic tools accounted for 33% of diagnostics used for NTDs and very few diagnostics had been subjected to regulatory assessment. The number of tests needed for each disease was less than 1 million units per annum, except in the case of two diseases, suggesting limited commercial value. Despite the nature of the market, and presumed insufficient return on commercial investment, acceptable levels of assurance on performance, quality and safety of diagnostics are still required. Priority actions include setting up an agile, interim, stepwise risk assessment mechanism, in particular for diagnostics of lower risk, in order to support national NTD programmes and their partners with the selection and procurement of the diagnostics needed to control, eliminate and eradicate NTDs.</p>
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