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June 2026

Congress Returns to CLIA Reform with Proposed LDT Framework

TDR Insider /

Newly filed Enhancing CLIA Act seeks to modernize clinical laboratory regulations A newly introduced federal bill could signal the next chapter in the long-running debate over how laboratory developed tests (LDTs) should be regulated in the United States. Not only does the Enhancing CLIA Act seek to explicitly keep LDT authority under CLIA, it also […]

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Updated Look and New Issue Frequency for Print

Commentary and Opinion by R. Lewis Dark /

Starting with this issue, The Dark Report is making two important changes. One will be immediately visible, and another concerns our deadline cycle. First, the more obvious change: Our print issue looks a bit different than last time you held it! We wanted to give a more modern look to our print layout without ripping

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Congress Returns to CLIA Reform with Proposed LDT Framework

Laboratory Compliance /

CEO SUMMARY: A newly introduced federal bill could signal the next chapter in the long-running debate over how laboratory developed tests (LDTs) should be regulated in the United States. Not only does the Enhancing CLIA Act seek to explicitly keep LDT authority under CLIA, it also assumes a more subtle role that the now disbanded

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What ‘White Collar/Blue Collar’ Testing Split Means for Labs

Lab Marketplace /

As in vitro diagnostics (IVD) manufacturers consolidate to chase high-margin precision medicine, medical laboratories must learn to navigate a market split into two distinct tiers: commodity-driven volume testing and high-value, data-driven genomics. That was a key message from an IVD panel convened at the 2026 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management.

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Federal Shift on Medicaid Fraud Offers Warning to Labs 


Lab Risk & Compliance /

CEO SUMMARY: While the announcement of the largest autism fraud case in DOJ history doesn’t directly pertain to clinical labs, it still indicates heightened scrutiny of Medicaid-funded healthcare services nationwide. Attorney Elizabeth Sullivan warns laboratories to closely review their Medicaid referral and test ordering patterns now to avoid getting caught in a future Medicaid dragnet.

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Alzheimer’s Data-Sharing Platform Hints at Lab Opportunities

Clinical Laboratory /

CEO SUMMARY: Savvy clinical lab decision-makers know that they must seek out new revenue streams beyond expanded test menus. Labcorp’s new AI platform for Alzheimer’s disease-related data analysis offers a useful case study to explore in that regard. However, there are ethical concerns with how laboratories and third-party vendors use patient diagnostic information, even if

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Federal Shift on Medicaid Fraud Offers Warning to Labs

Lab Risk & Compliance, Uncategorized /

CEO SUMMARY:While the announcement of the largest autism fraud case in DOJ history doesn’t directly pertain to clinical labs, it still indicates heightened scrutiny of Medicaid-funded healthcare services nationwide. Attorney Elizabeth Sullivan warns laboratories to closely review their Medicaid referral and test ordering patterns now to avoid getting caught in a future Medicaid dragnet. News

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Networking and Learning from Peers Prove to be Draws

Laboratory Information Systems, Uncategorized /

The Dark Report spends a large amount of space detailing the learnings from the dozens of sessions at the Executive War College. However, rarely do we discuss why clinical laboratory leaders choose to come to this annual flagship event. I wanted to find out more. The 2026 Executive War College took place April 28-29 in

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Labcorp and Quest Execs Support RESULTS Act Progress

Clinical Laboratory /

Chief executives at both Labcorp and Quest Diagnostics reported year-over-year revenue growth in the first quarter during recent earnings calls, especially in specialty and consumer testing. They also indicated the companies are watching the progress of the RESULTS Act in Congress in hopes that it will reform the unpopular Protecting Access to Medicare Act (PAMA).

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June, 2026, Intelligence

Lab Intelligence /

AI Moves Deeper into Laboratory Workflows OpenAI has launched “ChatGPT for Clinicians,” a free AI platform for verified US physicians, nurse practitioners, physician assistants, and pharmacists. Designed to support documentation, medical research, and workflow automation, the tool reflects the growing adoption of AI in healthcare. For clinical laboratories, the launch highlights how generative AI is

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