News

JD Supra5d
Judge Blocks FDA Regulation of Laboratory-Developed Tests
On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug ...
JD Supra11d
Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs
The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory ...
Judge Threatens Sanctions For Testing Lab’s Continued Pursuit of Rejected Arguments
The plaintiff "has functionally litigated these exact claims and arguments dozens of times before, without success or any ...
Multiple Sclerosis News Today2d
Octave’s MS disease activity test now available across US
Octave's MS disease activity test is now available across all 50 U.S. states to help guide clinicians' decisions about MS ...
Scientists Develop Revolutionary Blood Test for Head and Neck Cancer
The MyHPVscore test represents a successful translation of research from the laboratory to clinical practice. A Michigan ...
Morningstar5d
KingMed Is a Leading Independent Clinical Laboratory With Long-Term Tailwinds
KingMed is China's largest independent clinical laboratory in terms of clinical testing revenue. From 2016 to 2023, its revenue grew at a compound annual growth rate of 14.9%. It aims to deepen ...
Polish medical lab operator Diagnostyka's annual profit jumps on higher test volumes
GDANSK (Reuters) -Polish medical laboratory operator Diagnostyka reported on Thursday an 80.9% year-on-year jump in its full-year net profit, mainly due to higher test volumes and a rise in average ...
Physician's Weekly12d
A review of laboratory practices for CSF oligoclonal banding and associated tests.
Multiple sclerosis (MS) is a chronic autoimmune disorder affecting the central nervous system, often emerging in early adulthood and representing a leading cause of neurological disability in young ...