TAG:
diagnostic assays
Facing Down the Lab Assay Patent Monster
PATENT ROYALTIES FOR HOMOCYSTEINE TESTING are the subject of our lead story in this issue. (See pages 2-4.) It provides an early example of how patent-protected diagnostic tests can create budget-busting problems for hospital laboratories which perform those tests. The spectre of crushing r…
Homocysteine Patent Triggers Royalty Demand
CEO SUMMARY: Laboratory Corporation of America fought a patent infringement case against the holder of the homocysteine assay patent and lost after a five-year court battle. Now Competitive Technologies, Inc. (CTI), armed with its victory in federal court, is ready to negotiate royalty ar…
Hospital Labs Produce Moderate Cost Increases
ALL PATHOLOGISTS AND HOSPITAL LAB ADMINISTRATORS who feel beat up about endless budget cuts should take heart. During the period 2000-2002, the cost of laboratory services in hospitals increased by 18%. That is something to brag about—and here’s why! The lab services cost increase was less than …
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…
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…
Laboratory Medicine Goes Global
IN MY OPINION, THE ABILITY OF TWO ST. LOUIS HOSPITALS TO PROVIDE a sophisticated menu of reference testing for a developing nation located more than 12,000 miles away is remarkable. (See …
New Trends in 2003 Affect Clinical Lab Services
CEO SUMMARY: Here’s our current list of macro trends that affect clinical laboratories, updated from the last list in January 2000. One bold prediction is that Medicare, as we know it, is on the verge of a major meltdown. Employers and consumers are also new forces to be reckoned with b…
New Market Channel For Esoteric Testing
CEO SUMMARY: It’s a new marketing model for specialty esoteric tests that presents both clinical and financial challenges to hospital and health system laboratories. Niche labs offering esoteric tests are sending sales reps directly to physicians and bypassing pathologists and lab direc…
Major Changes at Dade Behring Soon to Be Visible In Lab Market
Its recent financial restructuring now complete, Dade Behring prepares a “brand building” campaign CEO SUMMARY: Dade Behring is poised to become a tough and high-profile competitor in the laboratory diagnostics marketplace. Earlier this month,…
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.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.