News

Federal Court 'Vacates in Its Entirety' the FDA's Costly and Onerous Lab Test Rule
A federal district court has struck a blow for medical innovation and patient empowerment by overruling the Food and Drug ...
JD Supra1d
Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act
On March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in ...
JD Supra2d
FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?
A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services.
Judge foils FDA plan to regulate lab-developed tests
A U.S. district judge foiled the Food and Drug Administration's plan put forth under the Biden administration to regulate lab ...
Medical News Today14d
4 Best Deficiency Tests And What Our Testers Have to Say
Once the lab receives the test, LetsGetChecked states a person can expect to receive their results within a few days. LetsGetChecked states it uses Clinical Laboratory Improvement Amendments (CLIA ...
NeoGenomics Completes Acquisition of Pathline
NeoGenomics has completed its previously announced acquisition of Pathline, LLC, a CLIA/CAP/NYS-certified laboratory based in ...
Fierce Biotech8d
Federal judge blocks FDA's regulation of lab-developed tests
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...
Predictive Oncology Reports Year-End 2024 Financial Results and Provides Corporate Update
Company continues to progress toward the signing of a definitive merger agreement with RenovaroPITTSBURGH, April 01, 2025 ...