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US Food and Drug Administration
2022’s Top 10 Lab Stories Confirm Challenging Times
By Robert Michel | 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 XXX, No. 5 – March 27, 2023
In this issue, The Dark Report outlines six themes at the upcoming Executive War College. These themes show EWC participants what is changing in the healthcare and lab testing sectors, along with effective responses that can advance their lab testing services while generating welcome new sources of revenue. In other news, ARUP Labs and the University of Utah share best practices for winning funding for MT training programs.
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