TAG:
lab assay
Elizabeth Holmes of Theranos Speaks at AACC To Skeptical PhDs, Pathologists, and Press
By Robert Michel | From the Volume XXIII No. 11 – August 15, 2016 Issue
CEO SUMMARY: Elizabeth Holmes, Founder and CEO of Theranos, Inc., was given the ideal platform by AACC to show the science behind her lab company’s much-touted diagnostic technologies. But in a surprise to the assembled audience, Holmes, accompanied by three PhDs on her team, chose to d…
Score for Theranos after AACC: Fail.
By Mary Van Doren | From the Volume XXIII No. 11 – August 15, 2016 Issue
This is an excerpt from a 1,600-word article in the August 15 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …
200-Analyte Medication Test Panel Adds Value for Physicians
By Joseph Burns | From the Volume XXIII No. 6 – May 2, 2016 Issue
CEO SUMMARY: Delivering more value with lab tests requires going beyond simply working with physicians to improve test utilization by focusing on unnecessary or inappropriate tests. PeaceHealth Laboratories in Oregon successfully executed a two-step strategy to add value with its testing …
At FDA, Laboratory-Developed Tests Are in the Crosshairs
By Mary Van Doren | From the Volume XXIII No. 4 – March 21, 2016 Issue
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…
Medicare Overstepped With Proposed Rules
By R. Lewis Dark | From the Volume XX No. 15 – November 11, 2013 Issue
FOR SEVERAL YEARS NOW, officials at the federal Centers for Medicare & Medicaid Services (CMS) have signaled their unhappiness with the status quo in how coverage guidelines and prices must be established for clinical laboratory testing and anatomic pathology services. These pag…
Broward Health’s Lab Pursues Multiple Ways to Cut Lab Costs
By Joseph Burns | From the Volume XX No. 15 – November 11, 2013 Issue
CEO SUMMARY: Tasked with cutting $2 million from their lab’s annual operating budget, the lab team at Broward Health System instituted changes that included a lab test formulary and ordering algorithms. In collaboration with physicians, these changes reduced the use of outmoded tests wh…
Theranos Won’t Discuss Disruptive Lab Technology
By Joseph Burns | From the Volume XX No. 13 – September 30, 2013 Issue
CEO SUMMARY: In a partnership with Walgreens pharmacies, Theranos Inc. announced that it will run clinical lab tests on “micro-samples” and collect these blood samples without venipuncture. Even as Theranos touts the patient-friendly benefits of its proprietary diagnostic technology, …
Analyzing Lab Bid Demo To Predict Its Outcome
By Robert Michel | From the Volume XIV No. 18 – December 31, 2007 Issue
CEO SUMMARY: After two decades of study and preparation, the Centers for Medicare & Medicaid Services (CMS) is pushing the laboratory profession toward the first pilot site in the Congressionally-mandated Medicare Clinical Laboratory Services Competitive Demonstration Project. Designe…
High Cost of New Assays Stretching Lab Budgets
By Robert Michel | From the Volume IX No. 7 – May 13, 2002 Issue
CEO SUMMARY: Growing numbers of hospital labs report that higher costs of new diagnostic tests have become a new management problem. That’s because diagnostic manufacturers are developing tests around a new business model, one that calls for higher pricing based on a premise of higher c…
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Volume XXVIII, No. 1 – January 19, 2021
THE DARK REPORT HAS DiSCOVERED that 3 major health systems with 372 hospitals have switched to a different CLIA accreditation organization over the past 18 months. All the details are examined here, including reasons why a health system might make such a switch. Also in this issue is an exclusive newsmaker interview with the CEO of a new company that is challenging the 70-year-standard Coulter Principle technology in hematology.
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