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...
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ftdoajarticles:oai:doaj.org/article:587deea4f3674df8b7eb42f87c48c4c8 2023-05-15T15:15:51+02:00 Landscape analysis of NTD diagnostics and considerations on the development of a strategy for regulatory pathways. Hye Lynn Choi Camilla Ducker Susie Braniff Daniel Argaw Anthony W Solomon Bettina Borisch Deusdedit Mubangizi 2022-07-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0010597 https://doaj.org/article/587deea4f3674df8b7eb42f87c48c4c8 EN eng Public Library of Science (PLoS) https://doi.org/10.1371/journal.pntd.0010597 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0010597 https://doaj.org/article/587deea4f3674df8b7eb42f87c48c4c8 PLoS Neglected Tropical Diseases, Vol 16, Iss 7, p e0010597 (2022) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2022 ftdoajarticles https://doi.org/10.1371/journal.pntd.0010597 2022-12-30T20:23:03Z 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 ... Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLOS Neglected Tropical Diseases 16 7 e0010597 |
institution |
Open Polar |
collection |
Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 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. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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 ... |
format |
Article in Journal/Newspaper |
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 |
title |
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_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_sort |
landscape analysis of ntd diagnostics and considerations on the development of a strategy for regulatory pathways. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2022 |
url |
https://doi.org/10.1371/journal.pntd.0010597 https://doaj.org/article/587deea4f3674df8b7eb42f87c48c4c8 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 16, Iss 7, p e0010597 (2022) |
op_relation |
https://doi.org/10.1371/journal.pntd.0010597 https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0010597 https://doaj.org/article/587deea4f3674df8b7eb42f87c48c4c8 |
op_doi |
https://doi.org/10.1371/journal.pntd.0010597 |
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PLOS Neglected Tropical Diseases |
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16 |
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e0010597 |
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