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

Alec Saitman

doi:10.1016/j.jmsacl.2023.02.004

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

J Mass Spectrom Adv Clin Lab. 2023 Feb 18:28:56-59. doi: 10.1016/j.jmsacl.2023.02.004. eCollection 2023 Apr.

Author

Alec Saitman¹

Affiliation

¹ Providence Regional Laboratories, OR, United States.

Abstract

•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.

Publication types

Review