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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Keeps you up-to-date on new diagnostic tests, testing trends and opportunities, and emerging test technologies
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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
Loper Bright Renews Interest in the VALID Act
The US Supreme Court decision that recently overturned the Chevron doctrine is influencing potential enactment of new legislation
September 2024 Labs in Court
Recent DOJ settlements continue to focus on issues involving medical necessity and marketer compensation
What Labs Need to Know About MolDX®
How the MolDX® program works, what it covers, and how it can support better test access, use, and reimbursement in the clinical lab
Special Report: The 2024 Lab Enforcement Landscape
Lab leaders should be wary of telemedicine arrangements, certain marketing firms, and unnecessary PGx and CGx testing
Syndromes Without a Name Bring Labs an Uphill Battle
In an era when genetic and genomic testing are theoretically affordable and accessible, why do so many patients remain undiagnosed?
Advances in Point of Care Tech Alter the Genetic Testing Landscape
How are advances in point-of-care testing altering the genetic testing landscape, and what does this mean for the clinical lab?
Molecular Mysteries in the Blood
The current landscape of molecular hematopathology—and what steps clinical labs can take to stay at the forefront of the discipline
The Latest Developments in Liquid Biopsy and ctDNA Testing
The latest developments in liquid biopsy and ctDNA testing and why they should be of interest to clinical laboratory professionals
Loper Bright and the Potential Impact on the Laboratory Industry
This webinar explains how Loper Bright could impact the laboratory industry and what it means for clinical lab operations
Oncology LDTs: How Cancer Labs Can Best Navigate the FDA’s Final Rule
This webinar shares how the FDA's final rule applies to oncology LDTs and what it means for precision medicine efforts
