TAG:
molecular assay
Lab Innovators Point Way At Executive War College
CEO SUMMARY: Now in its tenth year, this Executive War College attracted a record crowd, including laboratory leaders from Europe, Africa, South America, and Asia. The unexpected finding was that, along with the growing acceptance of Lean, Six Sigma and other quality management systems by…
Bi-Annual Look at Trends Reshaping Clinical Labs
CEO SUMMARY: Among other things, we declare the end to the heyday of the independent commercial lab company which offers a broad test menu to all types of office-based physicians. In its place springs forth the specialty or niche testing laboratory. Small and focused on a specific number …
Change Beneath Surface Marks 2004 Lab Stories
CEO SUMMARY: Presented here are THE DARK REPORT’S “Ten Biggest Lab Stories of 2004.” These are the events we consider most important to the lab industry during the year. However, in contrast to past years, 2004 lacked the types of blockbuster events which radically change and reshap…
TriPath Imaging and Ventana Sign Major Development Pact
IF THE NEW BUSINESS AGREEMENT between Ventana Medical Systems, Inc. and TriPath Imaging, Inc. is successful, then the anatomic pathology laboratory may have a very different look in future years. Last week, Ventana Medical Systems, Inc. announced a …
Molecular Diagnostics’ “Gap in Expectations”
CEO SUMMARY: This year’s Executive War College provided strong evidence that the twin trends of molecular diagnostics and Lean management methods are taking root within the laboratory industry. Each is a trend in its infancy. Molecular diagnostics will require considerable time before i…
Anatomic Path Trends Portend Deep Changes
CEO SUMMARY: Our biannual review of trends shaping the anatomic pathology profession reveals that a wide range of influences are active. The nation’s healthcare system is undergoing fundamental changes in how it views the quality of health services and how it will favor top-performing p…
Offering Molecular Tests Has Surprises & Pitfalls
CEO SUMMARY: Laboratories that offer some of the new assays based on molecular technologies often find themselves facing significant financial risk. That’s because payers are skeptical about new lab tests which come at a high price, but don’t offer substantial clinical benefit. One ea…
RFP Secrets To Use When Buying Molecular Tests
CEO SUMMARY: It often takes two to four years before payer coverage and reimbursement become stable. During that time, NorDx Laboratories wants the vendors who sell it new molecular assays to have some “skin in the game.” It accomplishes this by negotiating contracts that link the con…
2003’s Big Lab Stories Reflect Health Trends
CEO SUMMARY: At a minimum, 2003 proved to be a year of relative stability for the laboratory industry, as demonstrated by THE DARK REPORT’S “Ten Biggest Lab Stories of 2003.” The year was free of industry-wide crises and scan- dals. That allowed most laboratory administrators and pa…
No Disruptive Technology In Lab Industry’s Future
CEO SUMMARY: As new diagnostic technologies move through the development pipeline and into widespread clinical use, the scientific knowledge and skill sets needed by laboratory staff and management will change. The emphasis in laboratory medicine will evolve to include more molecular tech…
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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