Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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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
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
FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
Dx Deals: Labcorp Continues Dealmaking with Incyte Asset Acquisition in Washington State
The majority of Labcorp’s revenue growth in the first quarter came from clinical lab acquisitions
Brief AI Glossary Can Help Clinical Lab Managers Navigate a Litany of Terms
We explain what ‘tokens’ are, as well as what ‘GPT’ really means
Top 5 Clinical Trials Shaping Medicine in 2025
From precision oncology to gene editing, these standout trials could redefine how to diagnose and treat rare diseases and cancer
Common Blood Draw Challenges and How to Overcome Them
Hemolysis presents a risk when sample collection is done improperly
