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 discuss: a) her company’s new business strategy; b) an
Tag: lab assay
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.
SKEPTICS WHO WEREN’T EXPECTING MUCH from Theranos CEO Elizabeth Holmes at the recent American Association of Clinical Chemistry’s annual meeting were proved right: Instead of delivering scientific
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 services. First, the lab combined a proprietary test with a new care protocol to
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 members.
The Food and Drug Administration claims that clinical laboratories are marketing their (LDTs) laboratory-developed tests – which make up
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 while ensuring that the correct test or blood product was ordered for
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 pages have chronicled some of the analyses and reports commissioned by CMS over the past
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, it has provided no information about the science that supports this testing and the clinical validations
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. Designed to drive down the price Medicare pays for laboratory tests, the plan CMS described at the December
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 clinical value. Marketing campaigns for these new assays will become