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...

Descripción completa

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
Descripción
Sumario:• 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.

Ejemplares similares