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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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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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
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
EKRA 101: A Brief Backgrounder and How to Stay Compliant
How the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) came to be, what laboratory leaders should know about it, and how to comply
Expert Q&A: Full Approval for Alzheimer’s Blood Tests Not Far Off
Andreas Jeromin, PhD, chief scientific officer at ALZPath, discusses the current landscape of blood-based AD tests and their future.
Expert Q&A: A Promising Future for Alzheimer’s Blood Tests
Alison Green, PhD, head of laboratory sciences at Scottish Brain Sciences, discusses recent developments in AD blood tests
Doing More with Less
A new capillary blood collection system, the BD MiniDraw™, can improve the testing experience for both labs and patients
Anatomy of a Fall
Examining what led to record low BB/TM ABPath certification examination pass rates in 2022
Lab Company Takes Rare Step to Promote Heart Disease Test
Publishing peer-reviewed studies to tout the economic benefits of medical devices is fairly commonplace, but rare for a laboratory company
June 2024 Labs in Court
Examining DOJ and OIG investigations of labs and their owners: Recent cases show continued focus on the usual enforcement targets.