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Top Stories in 2025 Played Out in Courts, Capitol Hill

CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to incr…

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Insights on Innovative Tech and Running a Clinical Lab in 2026

CEO SUMMARY: William Morice II, MD, PhD, the CEO at Mayo Clinic Laboratories, discusses technology that intrigues him and the important steps clinical laboratory leaders can take to better steer revenue opportunities as they head into the new year. Morice also comments on …

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Fast, $17.5B Deal Lands Waters Corp. in IVD Market

WHEN BECTON DICKINSON  (BD) ANNOUNCED ITS INTENT to spin off its in vitro diagnostics (IVD) and life sciences units in February, few observers expected a deal to close just five months later. But now that such an agreement has occurred as of July 14, the buy…

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News Briefs on Alzheimer’s Detection

FDA-cleared IVD could replace scans There has been a significant amount of activity in recent weeks as it concerns tests to detect Alzheimer’s disease. Clinical labs and neuropathologists will want to keep a cl…

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IVD Companies Launch New Assays, Analyzers, Automation

Steep declines in SARS-CoV-2 test revenue were reported by the top in vitro diagnostics (IVD) companies in Q2 2023 earnings compared to a year earli…

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Hospital Lab Outreach Still Effective Revenue Strategy

CEO SUMMARY: Despite the challenges hospital and health system laboratory outreach programs face today, there are many ways they can remain viable, according to an outreach expert from Mayo Medical Laboratories. By taking specific steps to increase volume and the value they provide, lab o…

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Georgia Micro Lab Slashes TAT by Almost Two Days

CEO SUMMARY: Two projects to boost the performance of the microbiology laboratory at University Health Services in Augusta, Ga., significantly reduced test turnaround times in ways that contributed to improved patient outcomes. The first project was in 2016, when the lab introduced mass s…

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Why Pharma, Private Equity Want to Reshape Lab Industry

CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professio…

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A coming transformation: Control over important diagnostic technologies is about to change hands

This is an excerpt from a 2,920-word article in the March 26, 2018, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: He…

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Mass Spec Tests Struggle To Gain Insurers’ Attention

CEO SUMMARY: Since 2014, a toxicology lab at the University of Colorado has used mass spectrometry to offer low-cost, accurate multi-analyte test panels that can detect hundreds of therapeutic drugs and drugs of abuse. However, CU Toxicology’s chief medical officer says health insurers …

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