CLIA, Regulatory, & Accreditation
|3 min read
Nora Hess: ‘CLIA Regulations Were Written for an Earlier Time’
Long-time expert discusses the current regulatory environment for clinical labs
|3 min read
Ensuring Compliance: How to Get AI Diagnostic Tools Approved for Clinical Practice
A regulatory roadmap for AI diagnostic tool developmentSponsored by
|3 min read
Leveraging Regulatory and Best Practices as a Foundation for Scalable Clinical NGS
From validating bioinformatics platforms to finding qualified partners, there are many strategies clinical labs can adopt to stay in compliance
|2 min read
Five Hard-Hitting Quotes from the 2026 Lab Manager Leadership Summit
Words of Curtiss McNair, Jr., Stacey Metzler, and others can guide clinical lab managers
|3 min read
PFAS Exposure Is Accelerating Aging: What New Research Shows About ‘Forever Chemicals’
New research found links between PFAS exposure and advanced mortality- and metabolism-related aging, with effects dependent on sex and age
|2 min read
The US Is Driving a Public Health Emergency of International Concern
Experts call for global collaboration to mitigate the harms of US policy changes
|1 min read
DEA Places Bromazolam in Schedule I, Signaling New Lab Compliance Requirements
Forensic and toxicology labs handling or testing this designer benzodiazepine must follow updated Schedule I regulations
|2 min read
Amplified Sciences Achieves CAP Accreditation for Cutting-Edge Diagnostic Lab
Gold standard milestone clears the path for national expansion of PanCystPro™ assay
|1 min read
Standardizing Oncology Assays: A Guide to Cell Line-Derived Reference Materials
Identify the limitations of patient tissue controls in genetic testing and examine the verification data supporting cell line-derived standardsSponsored by
|1 min read
Move Past the Limitations of Synthetic Reference Standards in Cancer Research
A review of cell line-derived reference standards for the investigation and molecular profiling of myeloid malignanciesSponsored by
|5 min read
Medicare Is Experimenting with Having AI Review Claims—a Cost-Saving Measure That Could Risk Denying Needed Care
A new pilot brings some automated treatment decisions from Medicare Advantage to traditional Medicare
|3 min read
Regulating the Future: How the FDA Is Defining the Role of AI in Clinical Development
The FDA is embracing a data-driven, patient-centered approach to clinical trials
|2 min read
