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
10 Top CLIA Deficiencies for Labs and How to Avoid Them
Areas to address when preparing for your next CLIA inspection, based on recent data on top CLIA deficiencies
What the FTC’s New Noncompete Rule Means for Your Lab
The new rule, slated to go into effect September 4, will ban noncompete agreements for most workers, including those in the lab industry
Perfect Partners: Healthcare Quality and the Clinical Lab
How labs form an indispensable part of the CMS National Quality Strategy, helping to drive healthcare improvements and scientific growth.
July 2024 Labs in Court
Genetic testing related fraud was a theme in recent enforcement actions involving medical laboratories and lab testing
Becoming Proficient in Proficiency Testing
Quality expert Sten Westgard discusses the latest CLIA update: “It’s time to have performance goals built in this century”
Expert Q&A: Quality, Proficiency, and CLIA Updates
Lighthouse Lab Services chief quality officer Anna Hill offers advice on keeping your lab compliant with the latest CLIA changes.
When Hiring Laboratory Sales Reps, Managers May Want to Consider Non-Sales Backgrounds
Clinical laboratory sales training expert Peter Francis shares qualities to look for when hiring laboratory sales reps
Transitioning the Clinical Lab
What clinical laboratory professionals need to know about healthcare provision for transgender and nonbinary patients
Labcorp Goes on Spring Spending Spree
Most of Invitae's employees will be hired by Labcorp, which expects the deal to add about $275 million in annual revenue
LDTs Around the World
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions
