TAG:
IVD
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…
Enzo Biochem’s Lab Business Sold to Labcorp for $146M
By Scott Wallask | From the Volume XXX, No. 5 – March 27, 2023 Issue
COMMERCIAL LABORATORY CONSOLIDATION CONTINUES, this time with news earlier this month that New York City-based Enzo Biochem agreed to sell its clinical laboratory business to Labcorp. The deal points to the problem many clinical laboratori…
CURRENT ISSUE
Volume XXXI, No. 4 – March 18, 2024
An expert attorney analyzes the most recent cases of EKRA violations, showing how many labs could be in violation themselves. Also, a major cyberattack on Change Healthcare, owned by UnitedHealth Group, creates disruptions to providers around the country. Other news includes a look at the worldwide pathologist shortage.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.
Topics
- Anatomic Pathology
- Clinical Chemistry
- Clinical Laboratory
- Clinical Laboratory Trends
- Digital Pathology
- Genetic Testing
- In Vitro Diagnostics
- IVD/Lab Informatics
- Lab Intelligence
- Lab Marketplace
- Lab Risk & Compliance
- Laboratory Automation
- Laboratory Billing
- Laboratory Compliance
- Laboratory Equipment
- Laboratory Information Systems
- Laboratory Management
- Lean Six Sigma
- Managed Care Contracts
- Molecular Diagnostics
- Pathology Trends
- People
- Uncategorized