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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Federal Appellate Decision on EKRA Spells Out How Lab Marketers Can Violate the Law
If clinical lab managers instruct marketing personnel to engage in kickback practices, they also could be held legally accountable
CMS Clarifies CLIA Personnel Requirements in Rare Memo
Clinical labs gain flexibility in meeting regulatory standards while potentially reducing their costs
Expert Q&A: AMR Warnings Need to Be Louder, and It Just Can’t Be Up to Labs
John Osiecki of bioMérieux also discusses AI for outbreaks and regulation trends
Healthcare Fraud Takedown Reveals 4 Lessons for Clinical Labs
The $14.6 billion bust by federal prosecutors shows gaps that every laboratory should monitor
Could Labs Adopt a CLIA Framework for Regulating Clinical AI?
Learn how CLIA could be used as a blueprint to regulate emerging technologies in an effective and dynamic way
Dx Deals: QuidelOrtho Acquires LEX Diagnostics, Plans to Switch Out Respiratory Testing Platforms
The $100 million deal will take advantage of LEX VELO technology to detect influenza and SARS-CoV-2
Diagnostics Pipeline: Labcorp Launches Holistic Medicine Service
The company is offering whole panels and more than 1,000 assays in total to support the new products
Breath Biopsy Aims to Detect Lung Infections Early
A novel breath test that could transform Pseudomonas aeruginosa detection in cystic fibrosis patients
Future of Biomarkers in Multiple Sclerosis Care
MS expert Stephanie Buxhoeveden combines personal experience with scientific expertise to explore how biomarkers are transforming MS care
A Look at How CLIA-Exempt States Operate and Why This Setup Exists
Washington State’s Department of Health details how its medical testing site program meets federal standards
