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 LDTs in the United States.•The current VALID Act has flaws in its legislations which need to be addressed.