How the VALID Act could affect patient access to laboratory developed testing for therapeutic drug monitoring

• LDTs are important to lab medicine as they allow flexibility for laboratories to provide testing that patients need. • Many TDMs are LCMS-based and are considered LDTs. • Some TDMs currently have little to no options for obtaining FDA cleared testing. • The VALID Act may threaten the offering of L...

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Detalles Bibliográficos
Autor principal: Saitman, Alec
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Mini-Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9969055/
https://www.ncbi.nlm.nih.gov/pubmed/36861048
http://dx.doi.org/10.1016/j.jmsacl.2023.02.004
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author Saitman, Alec
author_facet Saitman, Alec
author_sort Saitman, Alec
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description • LDTs are important to lab medicine as they allow flexibility for laboratories to provide testing that patients need. • Many TDMs are LCMS-based and are considered LDTs. • Some TDMs currently have little to no options for obtaining FDA cleared testing. • The VALID Act may threaten the offering of LDTs in the United States. • The current VALID Act has flaws in its legislations which need to be addressed.
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spelling pubmed-99690552023-02-28 How the VALID Act could affect patient access to laboratory developed testing for therapeutic drug monitoring Saitman, Alec J Mass Spectrom Adv Clin Lab Mini-Review • LDTs are important to lab medicine as they allow flexibility for laboratories to provide testing that patients need. • Many TDMs are LCMS-based and are considered LDTs. • Some TDMs currently have little to no options for obtaining FDA cleared testing. • The VALID Act may threaten the offering of LDTs in the United States. • The current VALID Act has flaws in its legislations which need to be addressed. Elsevier 2023-02-18 /pmc/articles/PMC9969055/ /pubmed/36861048 http://dx.doi.org/10.1016/j.jmsacl.2023.02.004 Text en © 2023 THE AUTHOR https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Mini-Review
Saitman, Alec
How the VALID Act could affect patient access to laboratory developed testing for therapeutic drug monitoring
title How the VALID Act could affect patient access to laboratory developed testing for therapeutic drug monitoring
title_full How the VALID Act could affect patient access to laboratory developed testing for therapeutic drug monitoring
title_fullStr How the VALID Act could affect patient access to laboratory developed testing for therapeutic drug monitoring
title_full_unstemmed How the VALID Act could affect patient access to laboratory developed testing for therapeutic drug monitoring
title_short How the VALID Act could affect patient access to laboratory developed testing for therapeutic drug monitoring
title_sort how the valid act could affect patient access to laboratory developed testing for therapeutic drug monitoring
topic Mini-Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9969055/
https://www.ncbi.nlm.nih.gov/pubmed/36861048
http://dx.doi.org/10.1016/j.jmsacl.2023.02.004
work_keys_str_mv AT saitmanalec howthevalidactcouldaffectpatientaccesstolaboratorydevelopedtestingfortherapeuticdrugmonitoring

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