The Dark Report Archives

Global IVD Companies Issue Third Quarter 2024 Earnings

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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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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Internet Tracking Lawsuits Target Quest and Labcorp

Clinical Laboratory Trends / Robert Michel

CEO SUMMARY: Here is the clinical lab industry’s first intelligence briefing on how class action attorneys are filing lawsuits against healthcare providers—including clinical laboratories. The allegations are that providers are using internet tracking tools, such as those offered by Meta/Facebook and Google, that cause private patient and consumer information to become public. QUEST DIAGNOSTICS AND

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Insights from Q3 2024 Earnings Calls Point to a More Robust Lab Market

Clinical Laboratory / Robert Michel

FOR THE THIRD QUARTER OF 2024 (Q3 2024), both of the nation’s largest publicly traded laboratories—Labcorp and Quest Diagnostics—reported growing revenue, more emphasis on specialty testing and advanced diagnostics, as well as progress with acquisitions and partnerships. LABCORP: Grows Q3 Revenue 7.4%, Advances Acquisitions Labcorp, Burlington, N.C., shared these Q3 2024 and nine-month financial results

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