TAG:
IVD
News and Insights from AACC Meeting in Chicago
CEO SUMMARY: There was plenty of positive energy last month when the 72nd Annual Scientific Meeting and Exhibition of the American Association of Clinical Chemistry (AACC) took place in Chicago. Attendees seemed pleased to be gathering and networking in person. However, there was re…
Coverage, Reimbursement Still Difficult for New Lab Tests
CEO SUMMARY: Bringing a new proprietary diagnostic test to market is an arduous process. It takes patience and planning to complete the journey from test development to payer reimbursement. This slow process stems from the fact that the healthcare reimbursement system is fragmented,…
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…
CURRENT ISSUE
Volume XXXII, No. 7 – May 12, 2025
Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.
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