TDR Insider Archives

Pathologist Asks ChatGPT, Google Notebook to Predict LDT Trial Outcome

On his blog last month, pathologist Bruce Quinn, MD, PhD, published the answers provided by two artificial intelligence chatbots after he asked each to analyze the legal briefs submitted to federal courts in Texas where lab plaintiffs are challenging the FDA’s laboratory developed test (LDT) final rule. Both chatbots answered that a favorable ruling for […]

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Two Different LDT Lawsuits Are Combined in Federal Court

TDR Insider / Robert Michel

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 will continue to oversee the now-unified case as it moves forward. Both plaintiffs make similar

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Internet Tracking Lawsuits Are Targeting Quest and Labcorp

TDR Insider / Robert Michel

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 type of class action lawsuit is increasingly common. Such cases often claim that the healthcare providers’ use

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Four Independent Health Systems Launch ‘Longitude Health’

TDR Insider / Robert Michel

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 collaboration and innovation in ways that directly lead to better patient care at lower cost. If

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Lab Innovators in Europe Have Solutions for the USA

TDR Insider / Robert Michel

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 companies. One clever invention is an “autonomous blood drawing system” that automatically performs venipunctures and

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Uncertainty in the Market for Digital Path Products

TDR Insider / Robert Michel

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 common with pathologists when it is time to make

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Identifying Current Lab Trends from Labcorp and Quest Experience

TDR Insider / Robert Michel

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 operations, they are often first to experience and respond to new trends—whether its more

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What Labs with LDTs Must Do to Comply with the FDA’s LDT Rule

TDR Insider / Robert Michel

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 substantial staff time and costs that may outweigh the benefit to the lab

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Clinical Labs Face New Consumer-Driven Trend

TDR Insider / Robert Michel

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.” The Dark Report relates an investigative report by The Post, which states, “A new world of DIY testing is changing the

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