https://www.medtechdive.com/news/fda-regulate-lab-test-overhaul/715025/
Lab test overhaul: FDA to regulate LDTs as medical devices | MedTech Dive
Stricter review of new tests developed by laboratories is coming, but some fear the changes will be expensive, time-consuming and discourage innovation.
lab test
https://www.medtechdive.com/news/lab-developed-tests-what-now-analysis/745464/
A judge blocked the FDA’s plan to regulate LDTs. What now? | MedTech Dive
Jun 16, 2025 - One attorney said the ruling “isn’t quite the stake in the heart.”
what nowmedtech divejudgeblockedplan
https://www.labcorp.com/biopharma/central-labs/therapeutic-experience/companion-diagnostics
Companion Diagnostics Services for IVDs and LDTs | Labcorp
Labcorp is your strategic lab partner in companion diagnostic and in vitro diagnostic development, delivering CDx assay expertise, clinical validation and...
companion diagnosticsservices forivdsldtslabcorp
https://www.cspi.org/page/laboratory-developed-tests-ldts
Laboratory-developed tests (LDTs)
laboratorydevelopedtestsldts