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IVD
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. …
Important Court Rulings & Pending New Federal Law
IMPORTANT THINGS ARE HAPPENING WITH COURT DECISIONS AND PROPOSED FEDERAL LEGISLATION that will affect a substantial number of the nation’s clinical laboratories and anatomic pathology groups. In this issue of The Dark Report, you’ll be alerted to those developments we th…
Might VALID Act Support Be Waning in Congress?
CEO SUMMARY: Just weeks ago, events seemed to indicate that the Verifying Accurate Lea…
Passage of FDA Regulation of LDTs Inches Closer in the Senate
CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are many in the clinical laboratory profession who oppose any proposal to give the FDA regulatory oversight of LDTs. …
Lab Vendors Adjusting to Changing Sales Practices
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June 6, 2022 Intelligence: Late-Breaking Lab News
Monkeypox is the latest disease showing up in the United States. That means hospital laboratories will want to be ready to diagnose monkeypox cases that show up in their emergency departments. An official from the Centers for Disease Control and Prevention (CDC) says it is exploring the possib…
Intermountain Health Merges with SCL Health
CEO SUMMARY: Mergers and acquisitions involving large integrated delivery networks (IDNs) are not only reshaping the nation’s hospital industry. These transactions also transform the way hospitals organize their clinical laboratories. Last month’s merger of Intermountain Health …
IVD Firms Grow During 2022, but COVID-19 Revenue Dropped
MOST MAJOR IN VITRO DIAGNOSTICS (IVD) MANUFACTURERS started strong in 2022 as their base businesses regained steam and made up for the significant falloff in COVID-19 diagnostic test revenue. During first quarter 2022 earnings calls with invest…
2021 Closes with Two Major Lab Industry Events
Normally, the time around Christmas and New Year passes quietly, typically without any significant developments. Such was not the case for the clinical laboratory industry in the last month of 2021 because of two announcements, each of which confirms ongoing market trends in healthcare and the lab te…
Ortho Clinical Diagnostics to Be Acquired by Quidel
CEO SUMMARY: In an announcement released before the end of 2021, Quidel said it had signed an agreement to acquire Ortho Clinical Diagnostics (OCD) for $6 billion. Laboratories that are customers of either company should expect changes after the deal closes as Quidel moves to integr…
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.
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