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lab intelligence
Hurdles Continue When Labs Request Genetic Test Coverage
By Virchow | From the Volume XXXI, No. 13 – September 23, 2024 Issue
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Uncertainty in Market for Digital Path Products
By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue
CEO SUMMARY: These are uncertain times for many companies offering a range of digital pathology (DP) products to the nation’s pathologists. Sales lag behind projections that caused investors to pour money into numerous DP start-ups. One reason DP companies are not meeting sales goals is…
Identifying Current Lab Trends from Labcorp & Quest Experience
By Robert Michel | From the Volume XXXI, No. 11 – August 12, 2024 Issue
CEO SUMMARY: Many different factors influence the operations of clinical laboratories in the United States today. One good source of competitive business intelligence is for lab administrators to follow the quarterly earnings calls of the nation’s two biggest public lab corporations. Wi…
2023 Ranking of the World’s Top 13 IVD Corporations
By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue
BASED ON 2023 DIAGNOSTICS-RELATED REVENUE, four in vitro diagnostics (IVD) manufacturers continued to lead the global IVD market just as they did in 2022. They are: Thermo Fisher Scientific, Inc., Roche Holdings, Abbott Laboratories, and Danaher Corporation. Th…
Global IVD Companies Report First Quarter 2024 Earnings
By Robert Michel | From the Volume XXXI, No. 9 – July 1, 2024 Issue
IN THEIR INITIAL FINANCIAL REPORTING F…
ACLA Files Court Challenge to FDA’s Final LDT Rule
By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue
CEO SUMMARY: Discussing the FDA’s final LDT rule, one pathologist tracking this matter wrote, “In many ways, the FDA’s plan [final LDT rule] is like the guy who gets three wishes from a genie, and he asks for unlimited wishes.†ACLA and HealthTrackRx are challenging the FDA’s  
Significant Developments Are Shaping Lab Market
By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue
CEO SUMMARY: With 140 speakers and 1,000+ attendees, this year’s Executive War College again provided a comprehensive picture of the specific forces reshaping the U.S. market for lab testing services. Presented here is a smorgasbord of information and innovation shared by different spea…
Labcorp to Acquire Only Certain Lab Assets of OPKO’s BioReference
By Robert Michel | From the Volume XXXI, No. 6 – April 29, 2024 Issue
Following Labcorp’s announcement that it will acquire “select assets†of BioR…
Lab Market Fragmenting, Creating New Opportunities
By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue
CEO SUMMARY: Even as consolidation continues in the ownership of hospitals, health systems, office-based physicians, and clinical laboratories, there is a powerful trend of fragmentation quietly transforming the way providers—including clinical labs and pathology groups—serve patient…
Examining the Worldwide Pathologist Shortage
By Robert Michel | From the Volume XXXI, No. 4 – March 18, 2024 Issue
CEO SUMMARY: Demand for pathology services is growing faster than the number of pathologists available to meet that demand. This is true for the United States and most other nations. Consequently, efforts are underway to more accurately measure the number of pathologists practicing in eac…
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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