Month: December 2015

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 FDA LDT guidance. Among the interesting insights are that FDA officials will not be surprised if some labs file a lawsuit challenging …

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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 of LDTs. However, the full list …

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Letter from Congress to CMS Asks for Delay in PAMA Reporting

CLINICAL LABORATORY ASSOCIATIONS are using a letter-writing campaign to members of Congress as a last-minute Hail Mary attempt to head off the controversial lab price market reporting rule that CMS intends to implement after January 1. Both Democrats and Republicans in the U.S. House of Representatives and the U.S. Senate have signed a letter to …

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FDA Official Makes Case In Favor of LDT Guidance

CEO SUMMARY: Forty years ago, pathologists in hospital and academic labs worked closely with treating physicians to produce laboratory-developed tests for discrete clinical cases. Seeing that, the FDA decided not to regulate those tests, an FDA official said. Over time, however, use of LDTs became a serious concern when labs developing LDTs were no longer involved …

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Lab Stakeholders Take Action to Prevent Drastic Cuts in the Medicare Lab Fee Schedule

WITH MANY CLINICAL LABORATORY STAKEHOLDERS anticipating major revenue shortfalls due to the Protecting Access to Medicare Act lab test market price reporting rule that went into effect January 1, THE DARK REPORT reports overlooked news that, at the behest of clinical laboratory associations, elected officials in Congress have signed a letter that asks the Centers for Medicare & Medicaid Services to …

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December 28, 2015 Intelligence: Late Breaking Lab News

To advance the practice of precision medicine through better use of genetic testing, a new limited liability corporation (LLC) was formed. Participating in the LLC are North Shore-LIJ Health System, the nation’s largest urban health system, OPKO Health, Inc., a pharmaceutical company, and GeneDx, a division of Bio-Reference Laboratories (both lab businesses are owned by OPKO). …

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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 of questionable sales practices engaged in by defendants in the federal whistleblower lawsuit against Health …

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Manhattan Labs Gets Infusion of Equity Cash – February 11, 2013

CEO SUMMARY: Manhattan Labs tapped a private equity company for growth capital last month. The company says its strategy is to deliver concierge-level quality lab services to the high-end physicians and patients within the tri-state area of New York, New Jersey, and Connecticut. These are savvy healthcare consumers who seek the best care from the …

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