Landscape analysis of NTD diagnostics and considerations on the development of a strategy for regulatory pathways.
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 addres...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2022-07-01
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| Series: | PLoS Neglected Tropical Diseases |
| Online Access: | https://doi.org/10.1371/journal.pntd.0010597 |
| _version_ | 1798021978869727232 |
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| author | Hye Lynn Choi Camilla Ducker Susie Braniff Daniel Argaw Anthony W Solomon Bettina Borisch Deusdedit Mubangizi |
| author_facet | Hye Lynn Choi Camilla Ducker Susie Braniff Daniel Argaw Anthony W Solomon Bettina Borisch Deusdedit Mubangizi |
| author_sort | Hye Lynn Choi |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T17:23:30Z |
| format | Article |
| id | doaj.art-587deea4f3674df8b7eb42f87c48c4c8 |
| institution | Directory Open Access Journal |
| issn | 1935-2727 1935-2735 |
| language | English |
| last_indexed | 2024-04-11T17:23:30Z |
| publishDate | 2022-07-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS Neglected Tropical Diseases |
| spelling | doaj.art-587deea4f3674df8b7eb42f87c48c4c82022-12-22T04:12:27ZengPublic Library of Science (PLoS)PLoS Neglected Tropical Diseases1935-27271935-27352022-07-01167e001059710.1371/journal.pntd.0010597Landscape analysis of NTD diagnostics and considerations on the development of a strategy for regulatory pathways.Hye Lynn ChoiCamilla DuckerSusie BraniffDaniel ArgawAnthony W SolomonBettina BorischDeusdedit MubangiziAccess 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.https://doi.org/10.1371/journal.pntd.0010597 |
| spellingShingle | Hye Lynn Choi Camilla Ducker Susie Braniff Daniel Argaw Anthony W Solomon Bettina Borisch Deusdedit Mubangizi Landscape analysis of NTD diagnostics and considerations on the development of a strategy for regulatory pathways. PLoS Neglected Tropical Diseases |
| title | Landscape analysis of NTD diagnostics and considerations on the development of a strategy for regulatory pathways. |
| title_full | Landscape analysis of NTD diagnostics and considerations on the development of a strategy for regulatory pathways. |
| title_fullStr | Landscape analysis of NTD diagnostics and considerations on the development of a strategy for regulatory pathways. |
| title_full_unstemmed | Landscape analysis of NTD diagnostics and considerations on the development of a strategy for regulatory pathways. |
| title_short | Landscape analysis of NTD diagnostics and considerations on the development of a strategy for regulatory pathways. |
| title_sort | landscape analysis of ntd diagnostics and considerations on the development of a strategy for regulatory pathways |
| url | https://doi.org/10.1371/journal.pntd.0010597 |
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