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medical laboratory tests

2019’s Top 10 Lab Stories Reveal Major Laboratory Industry Trends

This is an excerpt of a 3,163-word article in the Dec. 16, 2019 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: There was plenty of bad news in 2019 for clinical labs and pathology groups. Yet lurking inside this new…

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Legal Briefs Explain Problems with PAMA Implementation

CEO SUMMARY: Several developments have moved the case forward since December when the American Clinical Laboratory Association filed suit in federal court against the Department of Health and Human Services. Inrecent weeks, ACLA filed for summary judgment; HHS responded with its own reque…

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SEC Charges Theranos with ‘Massive Fraud’

CEO SUMMARY: In an action against Theranos and two of its executives, the SEC said in a federal court filing this month that the company, CEO Elizabeth Holmes, and former COO Ramesh “Sunny” Balwani deceived investors into believing that the company’s portable blood analyzer could co…

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Diagnostic Error Rate Of 21% Revealed By Mayo Clinic Study

CEO SUMMARY: Researchers at the Mayo Clinic showed that only 12% of patients referred to Mayo physicians for a second opinion got a confirmation that their original diagnosis was complete and correct. In 21% of the cases, the diagnosis was completely changed. Among patients who got additi…

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PAMA Fee Cuts a Factor in Outreach Lab’s Sale

THROUGHOUT THE WORLD, THE UNITED STATES IS ENVIED for the quality and ready access to medical laboratory tests that it delivers to physicians and their patients. Yes, there are criticisms that healt…

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Official Makes Case in Favor of FDA LDT Guidance

IN THIS EXCLUSIVE NEWS COVERAGE of a public appearance by a key FDA official, THE DARK REPORT provides lab executives and pathologists with a more nuanced understanding about the thinking behind the proposed …

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Feds Show How Labs Took $500 Million from Medicare

CEO SUMMARY: In this second phase of the whistleblower case against three cardiology testing labs and a sales consulting company, federal prosecutors are requesting a jury trial against the individuals named in the court documents filed August 7. Federal investigators alleged t…

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Theranos, Capital Blue Sign Lab Test Agreement

CEO SUMMARY: With each passing month, Theranos is looking more like a traditional clinical laboratory company, based on how it is expanding its patient service center network and courier/logistics system into different regions while pursuing managed care contracts with health ins…

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Our Editor Describes Visit to Theranos Test Center

CEO SUMMARY: Theranos now operates wellness centers in Walgreens in Palo Alto, California, and Phoenix, Arizona. It continues to claim it is transforming the lab testing experience for patients and physicians. It says it can perform hundreds of lab tests, using a finger stick col…

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What’s New at Theranos? Lab Firm Expands in AZ

CEO SUMMARY: Over the past 18 months, Theranos has taken steps to enter the clinical lab marketplace. Across Greater Phoenix, Theranos now has specimen collection centers in about 40 Walgreens pharmacies. It is opening a CLIA lab facility in Scottsdale. Now that it is delivering…

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