TAG:
molecular assay
2006’s Top Lab Stories Identify New Threats
By Robert Michel | From the Volume XIII No. 17 – December 18, 2006 Issue
CEO SUMMARY: Presented here are THE DARK REPORT’S “Ten Biggest Lab Stories of 2006.” Compared to earlier years, 2006 was not transformative for the laboratory industry. But it was an eventful year, particularly influenced by Siemens’ decision to acquire DPC and Bayer Diagnostics, …
Acute Histotech Shortage Grows Across the USA
By Robert Michel | From the Volume XIII No. 16 – November 27, 2006 Issue
CEO SUMMARY: Pathology laboratories are enjoying steady increases in specimen volume and revenue as new molecular assays gain acceptance by clinicians. However, the supply of histotechnologists is failing to keep pace with growth in the volume of tissue-based testing. One executive who pl…
Supremes Rule Against LabCorp On Test Patent
By Robert Michel | From the Volume XIII No. 11 – August 14, 2006 Issue
CEO SUMMARY: It’s a bad news/good news outcome for pathologists and lab administrators hoping for clearer guidance on patents granted for DNA and other diagnostic technology. The bad news is that LabCorp gets no relief from lower court rulings that it infringed patents on homocysteine t…
Many Trends in AP Spell Lots of Change Ahead
By Robert Michel | From the Volume XIII No. 2 – February 6, 2006 Issue
CEO SUMMARY: Every second year, THE DARK REPORT releases its list of key trends in anatomic pathology. These trends help shape an understanding about the state of the pathology profession. Our current list includes 11 identifiable trends. This is not an auspicious sign for pathologists wh…
Lab Tests in Pharmacies, Genzyme, Healthe, Singing River Hospital, VA
By Robert Michel | From the Volume XII No. 15 – October 24, 2005 Issue
IT IS OFTEN SUGGESTED that pharmacies are a logical place to combine laboratory testing with prescription services. Such an arrangement would be consumer-friendly and has the potential to improve patient care while lowering costs. In Great Britain, the National Health Service has launched a pilot pr…
Top Ten Clinical Molecular Companies
By Robert Michel | From the Volume XII No. 13 – September 12, 2005 Issue
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Picking Winners and Losers For the Molecular Test Menu
By Robert Michel | From the Volume XII No. 12 – August 22, 2005 Issue
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 …
Molecular Diagnostics: How Beaumont Built A Successful Program
By Robert Michel | From the Volume XII No. 11 – August 1, 2005 Issue
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 Quest and LabCorp, The Story is “Molecular”
By Robert Michel | From the Volume XII No. 11 – August 1, 2005 Issue
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…
For Molecular Tests, Evaluate All Factors
By Robert Michel | From the Volume XII No. 8 – May 30, 2005 Issue
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…
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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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