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How Specialty Diagnostic Tests Connect with Lab Customers – 2

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 In this exclusive Q&A, Revvity’s Yves Dubaquie provides details about the in vitro diagnostics company’s priorities, including developing specialty tests and reviewing its business in China. Dubaquie also explains why clinical laboratories may need to consider hiring more technology-savvy workers in the future as the complexity of instruments grows. Yves Dubaquie, PhD, is a 30-veteran […]

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Congress Returns to CLIA Reform with Proposed LDT Framework

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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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Expect RESULTS Act Vote by the End of the Year

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Evidence at the 2026 Executive War College suggests a coming push in clinical lab advocacy, focusing on the RESULTS Act to establish a permanent, database-driven reimbursement model. Simultaneously, federal regulators have floated the idea of heightened scrutiny of genetic test spending, signaling that while lab test reimbursement rates may stabilize, compliance oversight could enter a

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Positioning the Clinical Lab as a Strategic Powerhouse

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The 31st Annual Executive War College in New Orleans showcased speakers who have re-imagined the diagnostic laboratory’s role from back-office utility to a primary driver of system-wide strategy and clinical excellence. A consistent theme came up during dozens of sessions at the conference: Clinical laboratories that lead integration efforts will define their own role in

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Allina Will Join Sutter and Focus on Digital Growth

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Minnesota-based Allina Health’s plans to join Sutter Health in California would create a multi-regional integrated delivery network backed by a $2 billion push into digital and outpatient care. As has been illustrated by past agreements and mergers, clinical laboratories for Allina face uncertainty in terms of centralized core lab functions and how testing may shift

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Ruling Limits Lab Vulnerability on Medical Necessity

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A federal appeals court ruling has established a legal “safe harbor” for clinical laboratories, shifting the burden of proof in False Claims Act cases. By allowing labs to generally rely on physician orders as evidence of medical necessity, the decision provides a new defense against whistleblower litigation. The case in question centered on the necessity

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Six Themes Will Define the 2026 Executive War College

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The 31st Annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management is just eight weeks away. From financial performance to digital pathology and AI, this year’s jam-packed conference will deliver practical solutions for today’s busy clinical laboratory executives. Despite stepping down last year from day-to-day duties, event founder Robert L. Michel’s influence will

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PAMA Cuts Averted Until 2027; Labs Must Plan Next Move

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Clinical laboratories have again avoided a potential financial disaster, at least for now, after Congress shifted PAMA cuts to test reimbursement rates until January 2027. However, the victory is temporary absent permanent PAMA reform. To that end, laboratory leaders need to push lawmakers to pass the RESULTS Act, with one healthcare attorney suggesting that labs

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FDA May Reclassify Oncology Companion Diagnostics to Class II Devices

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Regulatory attorneys indicate that the FDA’s move to reclassify oncology companion diagnostics to Class II medical devices could speed approvals and reduce costs for submissions. From a business perspective, the proposal could allow clinical laboratories to expand their testing options, bring more tests in house, and attract new investment. The public comment period for the

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Top Stories in 2025 Played Out in Courts and on Capitol Hill

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For clinical laboratory and pathology leaders, 2025 presented a year of profound transformation. Regulatory rulings, legislative efforts, technological innovation, and market consolidation reshaped the landscape for clinical labs. Here, members of The Dark Report can read our top 10 stories of the year. In a repeat from last year, regulation of laboratory developed tests (LDTs)

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