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
Author Information
Scott Wallask
Scott Wallask is senior editorial manager for Today’s Clinical Lab and G2 Intelligence. He has spent more than 25 years covering the health care and high-tech industries. A former newspaper reporter, he graduated from Northeastern University with a degree in journalism.
Posts by the Author
‘Full Speed Ahead’ with Test Results? Not So Fast
Lab scientists using testing equipment too quickly brings up training concerns in discussions at recent ADLM conference
Expert Q&A: Labs Must Take a Greater Role in Guiding Clinicians About Abnormal Data
Lee Fleisher, MD, advocates for clearer interpretation of test results by medical laboratory scientists
Special Report: The 2024 Lab Enforcement Landscape
Lab leaders should be wary of telemedicine arrangements, certain marketing firms, and unnecessary PGx and CGx testing
Special Analysis: Addressing Key Concerns Around the FDA’s Final LDTs Rule
Experts answer key questions related to laboratory-developed test regulation during G2 Intelligence webinar.
Special Analysis: Two Key Legislative Initiatives Labs Should Know About
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
Special Report: Will the COVID-19 Recovery Be Bumpier than Expected?
Though IVD and commercial lab Q3 2023 earnings reports held promising signs, Q4 2024 and FY2023 results tell a different story.
The Benefits of Penetration Tests in Labs
Cybersecurity expert explains the importance of such assessments, which simulate malicious attacks to identify IT vulnerabilities.
Quick Guide to Recent Changes We’ve Made to G2’s Reports
A new name comes with Lab Industry Advisor, but the goal of helping labs remains the same.
Compliance Tool: 8 Questions to Ask About Digital Pathology Business Arrangements
This checklist can help labs monitor their organization’s business arrangements that concern digital pathology to ensure compliance.
