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September 3, 2024, Intelligence: Late-Breaking Lab News

To challenge the federal Food and Drug Administration (FDA) final rule on laboratory developed tests (LDTs,) the Association for Molecular Pathology (AMP) filed a lawsuit on August 20, 2024, in the United States District Court for the Southern District of Tex…

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Machine Learning Poised to Give Clinical Labs New Capabilities

“One of the first questions I ask the laboratory team is ‘do you want to continue to be a factory or do you want to be a change agent in healthcare?’ They all answer that they want contribute to positive change.” —Michael Simpson …

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IVD and Lab Consolidation Reduces Choices for Labs

CEO SUMMARY: Since the launch of The Dark Report in 1995, consolidation of hospitals, physician groups, clinical labs, pathology groups, and IVD manufacturers has been a major trend every year. Toda…

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Ortho Clinical Diagnostics to Be Acquired by Quidel

CEO SUMMARY: In an announcement released before the end of 2021, Quidel said it had signed an agreement to acquire Ortho Clinical Diagnostics (OCD) for $6 billion. Laboratories that are customers of either company should expect changes after the deal closes as Quidel moves to integr…

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CLIA Lab Director Testimony Shows Risks to Pathologists

CEO SUMMARY: Elizabeth Holmes’ criminal trial is a case study for clinical lab directors in how not to run a medical lab, according to an attorney with 30 years of advising labs on CLIA-enforcement issues. During the trial, federal prosecutors cited the Clinical Laboratory Improve…

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