Tag: fda ldt guidance

LabCorp Now Larger than Quest, Two Labs Report 2015 Earnings

By Robert Michel, from the Volume XXIII No. 3 – February 29, 2016 issue

IN RECENT WEEKS, the nation’s two largest lab companies reported fourth quarter and full-year earnings for 2015. The earnings reports reveal how the paths of the two companies are diverging.

The companies are diverging because of a major acquisition made in February 2015, by Laboratory Corporation of America. LabCorp bought Covance Inc. in a deal valued at

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Official Makes Case in Favor of FDA LDT Guidance

By Mary Van Doren

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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Volume XXVI No. 2 – February 4, 2019

NOW THAT MOST HOSPITALS ARE INCLUDED as applicable laboratories that must report their PAMA private payer lab test price data to the Centers for Medicare and Medicaid Services, managers of those labs will benefit from the incisive analysis in this issue of the lessons learned during the 2017 PAMA reporting cycle. THE DARK REPORT further offers recommendations on how labs can do a better job of gathering and reporting their own data to CMS. Also, TDR delivers an exclusive analysis of why the Government Accounting Office's assertion that CMS will be paying billions more for Part B clinical lab tests is simply wrong.

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Tag: fda ldt guidance

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