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clinical testing

In HDL Case, Judge Imposes Damages, Penalties of $114 Million

LAST WEEK, A FEDERAL JUDGE in South Carolina issued an order imposing civil damages and penalties of more than $114 million on Tonya Mallory, the former CEO of Health Diagnostic Laboratory, in Richmond, Va., and two owners of the lab’s marketing partner, BlueWave Healthcare…

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Key Lab Trends Described At Executive War College

CEO SUMMARY: Innovative clinical labs and pathology groups are absorbing this year’s Medicare Part B price cuts while continuing to pursue opportunities to add value. A common theme from many speakers at last week’s Executive War College in New Orleans is that the lab must get mastery…

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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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Theranos Ends Patient Testing, Sued for Deceiving Investors

IN THE EARLY 1960S, the great bluesman Albert King wrote, “Born Under a Bad Sign,” which contained the unforgettable lyric, “If it wasn’t for bad luck, I wouldn’t have no luck at all.” That lyric almost describes what’s happened to Theranos Inc. since October 2015. Al…

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2015’s Top 10 Lab Stories Show Significant Changes

CEO SUMMARY: During 2015, two stories captured the full attention of most pathologists and clinical lab managers. One was how CMS intends to gather lab price market data as mandated by PAMA. The other was the continued efforts by the FDA to move ahead on proposed guidance for regulation o…

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Cleveland Clinic and related lab sue True Health Diagnostics

THE DARK REPORT is the only lab industry news source to recognize the significance of the lawsuit between the Cleveland Clinic Foundation and Cleveland HeartLab against a new lab company, True Health Diagnostics. It is the latest chapter in a string…

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Washington Post: Theranos Approached Military in 2012

SINCE THE WALL STREET JOURNAL published its exposé of Theranos Inc. in October, other media outlets have published the findings of their own investigations into various aspects of the lab company’s practices. One example is the disclosure by The Wall Street …

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True Health Diagnostics Sued by Cleveland Clinic Foundation, Cleveland HeartLab

IT’S GETTING DOWN AND DIRTY in the cardiology testing sector of the lab industry. No less than the Cleveland Clinic Foundation, along with Cleveland HeartLab, have filed a patent infringement lawsuit against a start-up lab in Texas. The defendant is True H…

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Might Lawsuits Come Next in Theranos Story?

CEO SUMMARY: Recent disclosures in the news indicate that an agreement between Theranos and Safeway has gone sour— after Safeway spent a third of a billion dollars to fulfill its part of the collaboration! Reporting by The Wall Street Journal c…

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Winning Bidder for HDL Connected to BlueWave

CEO SUMMARY: Events within the bankruptcy proceedings of Health Diagnostic Laboratory could be interpreted as setting the stage for the emergence of a laboratory company operated by executives-and marketed by a sales consultant-known to have had leadership roles in other lab companies accus…

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