How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
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Articles and Reports
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
August 2024 Labs in Court
COVID-19-related schemes dominated recent enforcement efforts, which include a national healthcare fraud enforcement action
FDA Watch: How Could the End of Chevron Impact the FDA and LDTs?
A lawsuit by a group of herring fishermen upended 40 years of legal precedent regarding how federal agencies interpret statutes
Clinical Lab Education: The Role of Virtual Reality
How virtual reality technologies can support clinical laboratory education efforts and what leaders should know about implementation
Getting to Know Your IT Colleagues
Technology experts Jaswant S. Tony and Neil Hillen explain what both clinical labs and IT departments can gain from closer collaboration
LLMs and the Lab
How artificial intelligence models can help labs, clinicians, and patients communicate with one another more effectively
Dx Deals: Quest Closes PathAI Partial Acquisition and Strategic Alliance
Deal is expected to give the lab giant a big boost in deploying artificial intelligence in the pathology space.
How to Prevent the Top 10 CLIA Deficiencies
A laboratory safety expert shares the most common CLIA citations from recent lab inspections, and how your lab can avoid similar problems.
ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Compliance Tool: Checklist for Avoiding 10 Top CLIA Deficiencies for Labs
Even the best labs can incur CLIA deficiencies when unprepared; this checklist can help your lab avoid some of the most common
