TAG:
the clinical laboratory
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 o…
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…
DAT: Should Patients Have Access to All Laboratory Tests?
CEO SUMMARY: Arizona’s new direct access testing law allows consumers and patients to have access to all laboratory tests without a physicians’ order. But one lab company decided not to offer all lab tests to consumers. Instead, executives at Sonora Quest Laboratories recognize that, …
Might Lawsuits Come Next in Theranos Story?
CEO SUMMARY: Recent disclosures in the news indicate that an agreement between Theranos and Safeway has gone sour— after Safeway spent a third of a billion dollars to fulfill its part of the collaboration! Reporting by The Wall Street Journal c…
New DAT Law, Competition Heat Up Phoenix Market
CEO SUMMARY: In Arizona, Theranos supported a new state law this year that allows patients to order lab tests without a doctor’s order. Since the law took effect, that law and the ultra-low prices offered by Theranos are drawing away some cash-paying customers from one lab company that …
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…
New ADLT Payment Rate May Force Lab to Close
CEO SUMMARY: Four Medicare Administrative Contractors currently pay $2,821 for CareDx’s AlloMap test. But under the proposal that CMS issued last month to overhaul the clinical lab fee schedule, CareDx would get only $644. Such a steep price cut would put the lab out of business because…
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…
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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