TAG:
lab assay
Elizabeth Holmes of Theranos Speaks at AACC To Skeptical PhDs, Pathologists, and Press
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.
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
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
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
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
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
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
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
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…
CURRENT ISSUE
Volume XXVII, No. 14 – October 5, 2020
THE DARK REPORT HAS ANALYSIS showing potential reasons why the Department of Justice has generated its largest lab fraud crackdown in history. $6B in allegedly fraudulent claims and 345 defendants may well be the result of an explosion in molecular test claims in 2019. Also, another competitor has entered the lab marketplace, this time with portable COVID-19 testing labs in trailers.
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