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lab intelligence
2023 Ranking of the World’s Top 13 IVD Corporations
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
IN THEIR INITIAL FINANCIAL REPORTING F…
ACLA Files Court Challenge to FDA’s Final LDT Rule
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
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
Following Labcorp’s announcement that it will acquire “select assets” of BioR…
Lab Market Fragmenting, Creating New Opportunities
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
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…
Labs Should Prepare for Arrival of ‘Perfect Storm’
CEO SUMMARY: In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming ref…
Who’s For and Against FDA Draft LDT Rule?
CEO SUMMARY: One analysis determined that 43.2% of the public comments were in support of the proposed LDT rule and 55.2% were in opposition to the rule. More telling, however, is that of the 2,900 comments in support, only 56 were not form letters! In contrast, about 1,300 individual com…
Google, Epic to Help Hospitals Migrate EHR Data to Cloud
GOOGLE CLOUD OF MOUNTAIN VIEW, CALIF., inked a new deal with Epic Systems designed to encourage healthcare providers to move electronic health record (EHR) data to the cloud. This relationship will include efforts to step up the use of artificial intelligence (AI) an…
CURRENT ISSUE
Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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