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US Food and Drug Administration
2024: Year of Decision for FDA Regulation of LDTs
FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION…
Year’s Top 10 Lab Stories Contain Surprises & Twists
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
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
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
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?
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?
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
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 XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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