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Judge foils FDA plan to regulate lab-developed tests

Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could guide their treatment when commercial tests don’t exist or aren’t precise ...
Tyler Morning Telegraph

HealthTrackRx Applauds Court Ruling to Vacate FDA’s Laboratory-Developed Test (LDT) Rule

DENTON, Texas, April 1, 2025 /PRNewswire/ — HealthTrackRx, a leader in molecular diagnostics and named plaintiff in the lawsuit challenging the U.S. Food and Drug Administration’s (FDA) regulation of ...
Healthcare Dive

5 steps to navigate the FDA’s new lab developed test rule

Laboratories are just beginning to assess the magnitude of operational changes needed to comply with a new federal rule expanding regulatory oversight of lab developed tests (LDTs). In a major shift, ...
MedPage Today

Future of Lab-Developed Tests Still Taking Shape

As the new Congress and a new administration start up, the fate of FDA-issued regulations on laboratory-developed tests (LDTs) is one of many issues that health advocates and lobbyists will be ...
Labroots

Best Practices for Clinical Labs in Turbulent Times

The FDA’s landmark final rule on Laboratory Developed Tests (LDTs) is set to transform the regulatory landscape for diagnostic laboratories. This webinar will provide biomedical diagnostics ...
Morningstar

Thermo Fisher Scientific Introduces New Laboratory Developed Test to Help Transplant Patients Receive the Right Dose of Critical Anti-Rejection Medication Sooner

Thermo Fisher Scientific Introduces New Laboratory Developed Test to Help Transplant Patients Receive the Right Dose of Critical Anti-Rejection Medication Sooner TacroType™ Pharmacogenetic ...