TAG:
molecular assays
Picking Winners and Losers For the Molecular Test Menu
CEO SUMMARY: In the 15 years it has operated a molecular diagnostics testing program, Beaumont Reference Laboratory (BRL) has learned important lessons on how to evaluate which specific molecular assays are ready for clinical introduction. It has also learned effective ways to anticipate …
For Quest and LabCorp, The Story is “Molecular”
CEO SUMMARY: Wall Street likes the potential of molecular diagnostics to infuse new revenues and operating profits into the laboratory industry. That is one reason Quest Diagnostics Incorporated and Laboratory Corporation of America are assertively seeking exclusive access to new molecula…
Molecular Diagnostics: How Beaumont Built A Successful Program
CEO SUMMARY: It was about 15 years ago when William Beaumont Hospital and Beaumont Reference Laboratories first began offering molecular diagnostic testing services to clinicians. This successful effort came about because of effective strategic planning, use of consulting expertise at key…
For Molecular Tests, Evaluate All Factors
CEO SUMMARY: When this hospital lab adopted molecular screening tests for Chlamydia trachomatis and Neisseria gonorrhoaea, physicians soon noticed a change in the rate of false positives. In researching the performance of the molecular assays compared to cultures, pathologists at this lab…
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…
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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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