TAG:
IVD
Gaining Network Access with Payers Is Often about Geography
By Virchow | From the Volume XXX, Number 15 – October 23, 2023 Issue
EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed…
Two Forces Push for More FDA Oversight of LDTs
By R. Lewis Dark | From the Volume XXX, No. 14 – October 2, 2023 Issue
CLINICAL AND GENETIC TESTING LABS MAY SUDDENLY FEEL THEMSELVES STUCK IN THE MIDDLE of a yin-yang situation when it comes to laboratory developed tests (LDTs). One force, the U.S. Food and Drug Administrati…
FDA Issues Proposed Rule to Further Regulate LDTs
By Scott Wallask | From the Volume XXX, No. 14 – October 2, 2023 Issue
CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnos…
Is Lab and IVD Consolidation Ready to Hit the Wall?
By R. Lewis Dark | From the Volume XXX, No. 13 – September 11, 2023 Issue
IN HUMAN HISTORY, ALL ERAS COME TO AN END. The majority of the time, the end of an era is disruptive and a new status quo emerges, with different winners and losers. Today, there is growing evidence that one era in c…
IVD and Lab Consolidation Reduces Choices for Labs
By Robert Michel | From the Volume XXX, No. 13 – September 11, 2023 Issue
CEO SUMMARY: Since the launch of The Dark Report in 1995, consolidation of hospitals, physician groups, clinical labs, pathology groups, and IVD manufacturers has been a major trend every year. Toda…
IVD Companies Launch New Assays, Analyzers, Automation
By Donna Marie Pocius | From the Volume XXX, No. 12 – August 21, 2023 Issue
Steep declines in SARS-CoV-2 test revenue were reported by the top in vitro diagnostics (IVD) companies in Q2 2023 earnings compared to a year earli…
2022 Ranking of the World’s Top 12 IVD Corporations
By Scott Wallask | From the Volume XXX, No. 11 – July 31, 2023 Issue
WHILE THE TOP FOUR IN VITRO DIAGNOSTICS (IVD) MANUFACTURERS kept their collective hold on the market compared to 2021, the big surprise was that Thermo Fisher Scientific’s…
July 31, 2023, Intelligence: Late-Breaking Lab News
By Scott Wallask | From the Volume XXX, No. 11 – July 31, 2023 Issue
Regulatory relief is on the way for clinical laboratories accredited by The Joint Commission. An overhaul of the Laboratory Accreditation Program’s standards, which goes into effect Aug. 27, will …
Despite COVID-19 Losses, IVD Executives Remain Upbeat
By Donna Marie Pocius | From the Volume XXX, No. 8 – May 30, 2023 Issue
Continuing declines in COVID-19 test revenues was a common theme during the first quarte…
IVD Firms Prepare for OTC, Home Test Market Expansion
By Robert Michel | From the Volume XXX, No. 6 – April 17, 2023 Issue
CEO SUMMARY: With public interest in home testing growing, some IVD manufacturers are preparing to serve a fast-expanding market for over-the-counter and at-home tests. IVD firms are banking on the…
CURRENT ISSUE
Volume XXXI, No. 6 – April 29, 2024
Laboratory managers will want to note that The Dark Report itself was targeted by the fraudsters who hit Change Health in a cyberattack. Also, one lab has some innovative methods of combatting the chronic staffing shortage, including hiring college graduates and students.
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