TAG:
ldt
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 …
December 7, 2015 Intelligence: Late Breaking Lab News
Last week, a joint laboratory accreditation agreement was announced by AABB and the American Association for Laboratory Accreditation (A2LA). The two associations will now collaborate to allow labs to obtain three assessments under one effort, including AABB accredit…
Opportunities Ahead for Labs That Prepare
AT THE END OF EVERY YEAR, IT’S ALWAYS SMART BUSINESS FOR EVERY LAB to peer into the future specifically to identify the best clinical and financial opportunities. With the New Year just a few week…
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…
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…
Theranos, Capital Blue Sign Lab Test Agreement
CEO SUMMARY: With each passing month, Theranos is looking more like a traditional clinical laboratory company, based on how it is expanding its patient service center network and courier/logistics system into different regions while pursuing managed care contracts with health ins…
April 20, 2015 Intelligence: Late Breaking Lab News
It’s a lawsuit that Quest Diagnostics Incorporated can’t seem to make go away. Last week in California, a federal judge ruled Hunter Laboratories and Surgical Pathology Associates (SPA) can continue to pursue their antitrust lawsuit against Quest Diagnostics. …
Theranos: Many Questions, but Very Few Answers
CEO SUMMARY: Winston Churchill famously said that “Russia is a riddle wrapped in a mystery inside an enigma.” That description could apply to Theranos, the company that claims it is poised to disrupt the entire clinical laboratory testing industry. In Phoenix, where Theranos is r…
Theranos: Many Questions, but Very Few Answers
WHEN A COMPANY THAT GOES PUBLIC WITH ITS GOALS, regularly and repeatedly declaring its lofty ambitions to do good for mankind by disrupting the status quo and replacing it with something new and wonderful, it invites itself to be judged by its actions and what it actually delivers. Since Thera…
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Volume XXXII, No. 7 – May 12, 2025
Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.
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