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lab executive
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 …
State of Clinical Lab Industry Likely to Be Mixed in 2016
CEO SUMMARY: Over the next 24 months, it will be essential for every clinical laboratory and anatomic pathology group to develop clinical and financial strategies that meet the changing needs of health insurers, hospitals and health systems, physicians, and patients. THE DARK REPORT provi…
Coming Next Year for Labs: PAMA, FDA, LDTs, and More
CEO SUMMARY: As 2016 approaches, nearly every lab organization is watching and waiting to learn how federal regulators at CMS and the FDA will move forward with plans to implement PAMA market reporting and regulation of laboratory-developed tests, respectively. Most knowledgeable observer…
Hospital CEOs Have Nothing to Fear from Theranos
FOR MORE THAN TWO YEARS, Theranos, the lab testing company that says it intends to disrupt the clinical lab industry, has been the subject of cover sto- ries in many prominent consumer and business publications. Its masterful public relations campaign seems to have touched almost eve…
Lab Professionals Long Knew of Challenges at Theranos
CEO SUMMARY: As THE DARK REPORT has continually reported, pathologists and medical laboratory professionals in the San Francisco and Phoenix markets were aware for most of the past year that Theranos was not delivering to patients and consumers the specific lab testing services it regula…
Will 2016 Bring Opportunity or Tribulations for Labs?
WE ARE JUST ABOUT EIGHT WEEKS FROM THE ADVENT OF 2016. Given the rapid transformation of healthcare that continues to unfold, it is timely to assess how clinical labs and pathology groups are likely to fare during the coming year. On the plus side, the ongoing evolution toward integration of clinica…
WSJ ‘Sticks’ Theranos, Raises Serious Questions
CEO SUMMARY: Following months of investigation, reporter John Carreyrou of The Wall Street Journal published back-to-back reports about aspects of Theranos that the…
Lab Professionals Knew of Challenges at Theranos
CEO SUMMARY: For most of the past year, pathologists and medical laboratory professionals in the San Francisco and Phoenix markets were aware that Theranos was not delivering to patients and consumers the specific lab testing services it regularly touted in news stories and at conferences…
Protecting Access to Medicare Act of 2014: Will price reporting rule drive small labs out of business?
This first assessment of the PAMA (Protecting Access to Medicare Act of 2014) proposed rule on market reporting of lab prices gives pathologists and lab executives insights about the good, the bad, and the…
Did Some Lab Execs ‘Get What They Wished For?’
BY NOW, MOST OF YOU HAVE LEARNED that, just 12 days ago, CMS issued the proposed rule that details how it will handle the private market price reporting mandate of the Protecting Access to Medicare Act of 2014 (PAMA). Almost immediately, critics spoke out about the obvious inequities that will re…
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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