November 2024

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

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Global IVD Companies Issue Third Quarter 2024 Earnings

In Vitro Diagnostics / Robert Michel

HERE IS A SUMMARY OF THE SECOND QUARTER FINANCIAL PERFORMANCE of the largest IVD manufacturers serving clinical laboratories. Lab managers and pathologists can use this information to track the market successes or setbacks by the different IVD vendors. These insights can be particularly helpful when considering different companies when it is time to replace or

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November 25, 2024, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

Disruption is happening in the consumer genetic testing marketplace. In recent weeks, news outlets in the United Kingdom reported that Atlas Biomed, a consumer genetic testing company founded in 2016, had simply “disappeared.” Malwarebytes said Atlas Biomed’s “London offices are closed, nobody answers the phone, and clients are no longer capable of accessing their online

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129,624 Genetic Tests in the United States

Laboratory Compliance / R. Lewis Dark

REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) by the federal Food and Drug Administration (FDA) certainly has the attention of lab executives and pathologists across the nation. As you will read here, since May two different lab industry lawsuits—now consolidated into one case—were filed in a federal court in Texas and each challenges the FDA’s statutory

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Two Different LDT Lawsuits Combined in Federal Court

Laboratory Compliance / Robert Michel

CEO SUMMARY: 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

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Pathologist Frederick Kiechle, MD, Molecular Pioneer, Dies at 78

Pathology Trends / Robert Michel

Clinical pathology lost one of its greatest practitioners when pathologist Frederick L. Kiechle, MD, PhD, FCAP, of Cooper City, Fla., died on July 30, 2024, at the age of 78. Kiechle—known as Fritz to his colleagues and friends—was continually at the forefront of laboratory medicine. In the late 1980s he was among the first pathologists

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Latest Kaufman Hall Report: 40% of Hospitals Losing Money

Clinical Laboratory Trends / Robert Michel

MANY HOSPITALS REPORT HEALTHIER FINANCIAL PERFORMANCE in the past 18 months. At the same time, a large proportion of U.S. hospitals have negative operating margins. This means the gap is widening between the group of hospitals with positive operating margins, compared to hospitals with negative operating margins. This has implications for clinical laboratory administrators in

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Proven Ways to Improve Pathologist Productivity and Compensation

Pathology Trends / Robert Michel

CEO SUMMARY: There is now extensive data from 1,400 pathologists serving in 230 pathology groups that show certain clinical and business strategies can lift a group’s collected revenue and increase the total annual compensation of the group’s pathologists. This is the first of a series of intelligence briefings that presents the findings from a study

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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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Getting Test Claims Paid & Class Action Lawsuits

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

When you crack open this issue of The Dark Report, you will find it organized around two primary stories. One story introduces you to a new type of legal attack on healthcare providers—including clinical laboratories—by class action lawyers. The second story delivers to you a comprehensive look at which lab test claims are getting paid

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