TAG:
US Food and Drug Administration
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…
2024: Year of Decision for FDA Regulation of LDTs
By R. Lewis Dark | From the Volume XXX, Number 18 – December 26, 2023 Issue
FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION…
Year’s Top 10 Lab Stories Contain Surprises & Twists
By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue
CEO SUMMARY: With the SARS-CoV-2 pandemic now in the rearview mirror of the nation’s clinical labs and pathology groups, the important news stories of 2023 were mostly about developments where the consequences will influence laboratory operations in coming years. Artificial intelligence…
2022’s Top 10 Lab Stories Confirm Challenging Times
By Scott Wallask | From the Volume XXIX, No. 17 – December 12, 2022 Issue
CEO SUMMARY: There are valuable insights to be gleaned from The Dark Report’s “Top 10 Lab Industry Stories for 2022.” Several of this year’s story picks involve external forces reshaping healthcare in the United States in profound ways. Other story picks for 2022 illustrate …
Top Public IVD Companies Report Q3/Q4 2022 Earnings
By Robert Michel | From the Volume XXIX, No. 17 – December 12, 2022 Issue
IT WAS A MIXED BAG OF THIRD QUARTER FINANCIAL RESULTS for the nation’s largest in vitro diagnostics (IVD) manufacturers, with COVID-19 testing volume a contributing factor. Fluctuating demand for SARS-CoV-2 testing proved perplexing, as some IV…
December 12, 2022, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 17 – December 12, 2022 Issue
Is it time to allow consumers to do at-home testing for influenza? Given the already-raging influenza season—flu-related hospitalizations doubled the week of Nov. 20 compared to a week earlier, according to the Centers for Disease Control and Prevention—the STAT medical news site ra…
Might LDT Regulation Bill Support Be Waning in Congress?
By Robert Michel | From the Volume XXIX, No. 10 – July 18, 2022 Issue
This is an excerpt of an 833-word article in the July 18, 2022 issue of THE DARK REPORT. The full article is available to members of The Dark Intelligence Group. …
Might VALID Act Support Be Waning in Congress?
By Robert Michel | From the Volume XXIX, No. 10 – July 18, 2022 Issue
CEO SUMMARY: Just weeks ago, events seemed to indicate that the Verifying Accurate Lea…
In Post-COVID-19 Market, IVD Manufacturers Face Supply, Staff Challenges
By Robert Michel | From the Volume XXIX, No. 10 – July 18, 2022 Issue
CEO SUMMARY: After making billions during the COVID-19 pandemic, in vitro diagnostics (IVD) manufacturers must now adjust their strategies and relationships with clinical laboratory customers. Because many contracts for automated instruments are coming due, some IVD companies have t…
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.
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