CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to increase regulatory scrutiny and costs for organizations creating […]
Top Stories in 2025 Played Out in Courts, Capitol Hill
Much like 2024, the FDA’s LDT final rule took the spotlight, but this time for a much different reason
- By Scott Wallask
- > From the Volume XXXII, No. 18 - December 29, 2025 Issue
- Tags: Abbott, acla, AI, Aignosics, American Clinical Laboratory Association, american society for clinical pathology, AMP, anti kickback statute, APHL, Arrayit Laboratories, artificial intelligence, ASCP, association for molecular pathology, Association for Public Health Laboratories, Becton Dickinson, biomarker quantification, CDC, Centers for Disease Control and Prevention, CLIAC, Clinical Laboratory Improvement Advisory Committee, Community Health Systems, Companion diagnostics, Danaher, Department of Health and Human Servies, digital pathology, digital slides, disease subtype classification, DOJ, ehr, EKRA, electronic health record, Eliminating Kickbacks to Recovery Act, FDA, final rule, flow cytometry, Food and Drug Administration, foundation models, genomics, HHS, HIPAA, hospital outreach, immunology, in vitro diagnostics, IVD, lab intelligence, LabCorp, laboratory-developed test, ldt, liquid chromatography, machine learning, Mark Schena, mass spectrometry, Mayo Clinic, Medicare, molecular diagnostics, multiplex testing, Nvidia, outcome prediction, PAMA, PAMA reform, personalized medicine, pharma, precision medicine, Protecting Access to Medicare Act of 2014, Quest Diagnostics, Reforming and Enhancing Sustainable Updates to Laboratory Testing Services Act, Results Act, Robert F. Kennedy Jr., Roche, Standford Health Care, Thermo Fisher, US Department of Justice, US District Court Judge Sean Jordan, Vacancy Survey, Waters Corp.
