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lab executive
At FDA, Laboratory-Developed Tests Are in the Crosshairs
This article is an excerpt from a 600-word article in the March 21 issue of THE DARK REPORT. Full details of FDA’s laboratory-developed test guidance and recent actions against labs that are marketing LDTs are included in the original article, available to paid m…
March 21, 2016 Intelligence: Late Breaking Lab News
Tougher times in the clinical lab testing market have claimed another lab company. On February 28, Artherotech, Inc., posted a notice on its website stating that it had closed permanently, as of that date. Along with its several hundred employees, Artherotech’s closure caught many…
Understanding the Future Of Laboratory Medicine
CEO SUMMARY: Healthcare’s transformation is now far enough along that most clinical labs and pathology groups are either feeling the financial pain or are excitedly developing ways to deliver more value from lab testing services. On April 26-27, at the 21st annual …
LabCorp Now Larger than Quest, Two Labs Report 2015 Earnings
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 Cor…
How Mentors Can Best Train Young Lab Leaders
CEO SUMMARY: Mentoring will be the theme of a special learning track at this year’s Executive War College. Two nationally-respected experts on mentoring and leadership development will work with participating lab mentors and mentorees to help them advance their mentoring relationship. A…
Newsmaker Interview: Matthew Hawkins
CEO SUMMARY: By now, most pathologists and clinical laboratory administrators recognize that effective use of information technology will be a critical success factor as healthcare systems transform to do population health management and to use “big data” with value-based payment mode…
LabCorp to Purchase Pathology, Inc. in Calif.
CEO SUMMARY: It is one of those clinical laboratory deals that was announced before the end of 2015. Laboratory Corporation of America said it will acquire most of the operating assets of Pathology Inc., of Torrance, California, and that the acquired lab “will cease operations” upon t…
Direct Access Test Laboratories Targeted by NY State Attorney General
CEO SUMMARY: Following an investigation of two lab companies providing direct access testing in New York State, the New York Attorney General entered into agreements with each lab company. Direct Laboratories, LLC, of Mandeville, Louisiana, agreed to cease offering DAT services in New Yor…
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 L…
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 …
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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