TDR Insider
Two Different LDT Lawsuits Are Combined in Federal Court
Different lawsuits challenging the FDA’s LDT rule were filed in recent months by the American Clinical Laboratory Association and the Association for Molecular Pathology. Both lawsuits were filed in the U.S. District Court for the Southern District of Texas, which ...
Internet Tracking Lawsuits Are Targeting Quest and Labcorp
QUEST DIAGNOSTICS AND LABCORP, THE TWO GIANTS OF THE U.S. CLINICAL LABORATORY BUSINESS, are among many companies across a wide range of industries facing class-action lawsuits over their use of tracking technologies designed to facilitate online advertising. This ...
Four Independent Health Systems Launch ‘Longitude Health’
For the second time in the past 16 months, respected health systems have taken steps to collaborate specifically to advance value-based care. Longitude Health joins Risant Health as the newest attempt to bring together different health systems and foster collaboratio...
Lab Innovators in Europe Have Solutions for the USA
Rapid advances in a wide range of technologies over the past 15 years are enabling entrepreneurs to create transformative products for use by clinical laboratories and anatomic pathology groups. The Dark Report recently toured Europe to visit several such innovative companie...
Uncertainty in the Market for Digital Path Products
These are uncertain times for many companies offering a range of digital pathology (DP) products to the nation’s pathologists. Sales lag behind projections that caused investors to pour money into numerous DP start-ups. One reason DP companies are not meeting sales goals is the inherent caution ...
Identifying Current Lab Trends from Labcorp and Quest Experience
Many different factors influence the operations of clinical laboratories in the United States today. One good source of competitive business intelligence is for lab administrators to follow the quarterly earnings calls of the nation’s two biggest public lab corporations. With coast-to-coast oper...
What Labs with LDTs Must Do to Comply with the FDA’s LDT Rule
Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This compliance will require subs...
Clinical Labs Face New Consumer-Driven Trend
THERE IS A NEW CLASS OF CLINICAL LABORATORIES THAT ARE BUILDING MOMENTUM in the United States today. These are labs serving what The Washington Post described as a "new world of DIY [do-it-yourself] testing."...
ACLA Files Federal Court Challenge to FDA’s Final LDT Rule
BATTLE LINES ARE NOW DRAWN ON WHAT IS PROBABLY THE BIGGEST CONFRONTATION between the clinical laboratory industry and federal regulators in the past 50 years. On May 29, the American Clinical Laboratory Association (ACLA) with co-plaintiff HealthTrackRx filed a ma...
New CISA Proposed Rule Mandates Rapid Reporting of Cyberattacks
There is another federal rule that will require compliance by clinical labs. An agency of U.S. Dept. of Homeland Security published a draft rule on April 4 that requires certain organizations—including hospitals, clinical labs, and pathology groups—to report, within 72 hours, any cyberattack and ...
Don’t Be at the Mercy of the Tumultuous Healthcare Revolution
Subscribe to The Dark Report for as little as $15.27 per week.
Get the most expert business intelligence for clinical laboratories and pathology groups available today. Subscribe to The Dark Report.
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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.