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
AI: With the Lab Every Step of the Way
Artificial intelligence models have a valuable role to play in each phase of the total testing process.
FDA Watch: Agency Opens New Pathway for STI At-Home Sample Collection Kits
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
Roche & Quest Establish Toeholds in Emerging Alzheimer’s Blood Testing Market
While Roche has an early lead, Quest recently made key moves to improve its position in the AD patient-initiated blood testing market.
Special Report: The OSHA Inspection Process and How to Survive It
The basics of how the OSHA inspection process works and how laboratories can successfully navigate it.
Profiling Pathogens for Public Health
Genomic epidemiology can provide insights into pathogen transmission and evolution—and facilitate better countermeasures against infectious disease.
The Diagnostics Pipeline: FDA Approves First Ever Fentanyl Test Strips for OTC Use
Approval for OTC use of a urine drug test that can be performed by non-CLIA facilities could help expand accessibility, expert says.
A 21st Century Response to the Cures Act
Patients’ unfettered access to complex test results can lead to confusion and distress—but generative AI can help.
Expert Q&A: What’s Next in Next-Generation Sequencing?
Crystal Girod, MSc, of Beckman Coulter Life Sciences discusses recent developments in NGS and their impact on clinical diagnostics.
December 2023 Labs in Court
A settlement for kickback allegations, prison time for lab owners convicted of COVID-19 fraud, and 10x Genomics gets OK for lawsuit.
Procedural Coding Changes to Note for 2024
Key 2024 coding changes for laboratories and tips for ensuring proper implementation into chargemasters and fee schedules.
