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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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
August 2023 Labs in Court
Last month’s key cases involved the outcome of a UHC lawsuit and fines for misleading claims about a COVID-19 test.
Addressing the Challenges of Bile Acid Diarrhea Diagnosis
A new five-metabolite blood test designed by algorithm could simplify and speed up this challenging diagnosis.
Using the IQCP Process to Improve CLIA Compliance and Lab Testing System Quality
Individualized quality control plans offer flexibility and the capacity to seamlessly adopt new nonwaived tests, practices, and technologies.
Can Ophthalmic Biomarkers Offer Insights into Brain Pathologies?
Protein levels in the vitreous humor may have the potential to support the diagnosis and staging of neurodegenerative diseases.
Simplifying At-Home Tests with AI
A new assay uses AI-optimized enzymes to simplify and increase the accuracy of rapid pathogen detection.
Combating Cervical Cancer: Where Do We Stand?
Accessible screening tests and inclusive management strategies may limit the global cervical cancer incidence rate.
The Diagnostics Pipeline: FDA Launches Pilot for Cancer Companion Diagnostic LDTs
New program aims to provide greater transparency on the recommended performance characteristics of such tests.
CMS Provides New Guidance on When International Labs Must Seek CLIA Certification
Recently released Centers for Medicare and Medicaid Services guidance shares when CLIA regulations apply to international labs.
Congress Moves to Require Medicare Coverage of Multi-Cancer Early Detection Tests
Federal lawmakers have renewed efforts to pass legislation ensuring Medicare coverage of multi-cancer early detection (MCED) tests.
Whistleblowers: SCOTUS Gives DOJ Wider Authority to Dismiss Meritless Qui Tam Cases
Ruling could spell good news for labs and other healthcare providers targeted by whistleblowers in False Claims Act qui tam lawsuits.