TAG:
diagnostic assays
Key Trends Drive Change for Clinical Laboratories
By Robert Michel | From the Volume XIV No. 1 – January 8, 2007 Issue
CEO SUMMARY: Technology plays an ever-growing role in reshaping the organization and operation of clinical laboratories. New technologies figure prominently in THE DARK REPORT’S 2007 list of key trends in the clinical laboratory industry. Technological advances in instr…
There is Steady Convergence In Lab Operations Worldwide
By Robert Michel | From the Volume XIII No. 17 – December 18, 2006 Issue
IS THERE AN ACCELERATING CONVERGENCE OF LABORATORY OPERATIONS by major clinical laboratories throughout the world? In recent weeks, THE DARK REPORT has seen tantalizing evidence that the answer to this question should be “yes.” This trend has strategic implications for independent commercial lab…
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, …
Pathology Lets the Oncology Cat Out of the Bag
By R. Lewis Dark | From the Volume XIII No. 15 – November 6, 2006 Issue
BECAUSE OF GENETIC TECHNOLOGY, the profession of anatomic pathology may be poised for a golden age. The range of new technologies and diagnostic assays heading for clinical use have the potential to give pathologists the ability to detect disease with greater precision. They will also allow pathologi…
Bio-Rad Buys Ciphergen’s Proteomics Technology
By Robert Michel | From the Volume XIII No. 12 – September 5, 2006 Issue
PROTEOMICS IS EXPECTED TO BE ONE of the most active areas in molecular diagnostics and Bio-Rad Laboratories, Inc. has just staked a major claim to a promising proteomic technology. In a transaction announced on August 18, 2006, Bio-Rad will acquire the proprietary proteomics instrum…
More IVD Consolidation: DPC Sells to Siemens
CEO SUMMARY: It is a significant acquisition, and not just because Diagnostic Products Corporation has a major presence in immunodiagnostics. Siemens Medical Solutions is one of the dominant competitors in radiology. Its willingness to pony up almost $2 billion t…
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…
Bi-Annual Look at Trends Reshaping Clinical Labs
By Robert Michel | From the Volume XII No. 2 – January 24, 2005 Issue
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 …
Medicare Changes Policy On New Med Procedures
By Robert Michel | From the Volume XI No. 16 – November 22, 2004 Issue
CEO SUMMARY: Faced with a literal tidal wave of new medical procedures, new therapeutic drugs, and new diagnostic tests, Medicare is crafting a unique strategy. As a new clinical option reaches the market, Medicare will reimburse—but only if the patient participates in a clinical study …
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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