The Dark Report Archives

September 3, 2024, Intelligence: Late-Breaking Lab News

To challenge the federal Food and Drug Administration (FDA) final rule on laboratory developed tests (LDTs,) the Association for Molecular Pathology (AMP) filed a lawsuit on August 20, 2024, in the United States District Court for the Southern District of Texas. This is the second lab industry lawsuit challenging the LDT rule to be filed […]

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Federal Court Issues Ban on FTC’s Noncompete Rule

Laboratory Compliance, Laboratory Management / Robert Michel

BY NOW, MOST CLINICAL LAB MANAGERS AND PATHOLOGY PRACTICE ADMINISTROATORS ARE AWARE of the Federal Trade Commission (FTC) rule that bans noncompete agreements in virtually all employment contracts in the United States. The final rule was to take effect on Sept. 4, 2024, and applies to most private, for-profit business entities, which includes most clinical

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Watch Out Pathologists! They’re Coming for Histology!

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

For any lab that depends on revenue from its histology laboratory, this issue of The Dark Report has important intelligence about a serious threat to this existing business model. One of your biggest, best-financed competitors is preparing to make a foray into this market segment of lab testing. I direct you to the sidebar with

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Watch Out Pathologists! They’re Coming for Histology! Read More »

How Is COVID-19 Evolving? It’s Not Like Flu or Colds

Clinical Laboratory Trends / Robert Michel

CEO SUMMARY: It’s been 53 months since the SARS-CoV-2 virus triggered the worst global pandemic since 1918’s influenza pandemic. The coronavirus continues to surprise public health officials as new variants are detected, along with a multi-year pattern of summer surges in new cases. The pandemic made wastewater testing an essential tool for public health officials

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Clarapath Raises $36 Million for Automated Histology Solution

Digital Pathology / Robert Michel

AS THE HISTOLOGY WORKFORCE STRUGGLES TO KEEP UP WITH RISING CASE DEMAND, Clarapath—a Hawthorne, N.Y. company intent on changing the way laboratories process human tissue—recently raised $36 million in funding for its SectionStar tissue sectioning and transfer robot. Leading the recent funding round was Northwell Ventures, the for-profit arm of Northwell Health, New York, N.Y.

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New Huron Survey Illuminates Consumer Healthcare Trends

Clinical Laboratory Trends / Robert Michel

REGULARLY, THE DARK REPORT POINTS OUT THAT consumers are an important force in healthcare’s transformation. Those clinical laboratories wanting to stay in the forefront of diagnostic testing services would be wise to heed emerging trends in consumer preferences. The latest sign of those trends comes from Huron Consulting Group, which issued a report based on

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Identifying Current Lab Trends from Labcorp & Quest Experience

Laboratory Management / Robert Michel

CEO SUMMARY: 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

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HHS Issues Final Rule to Deal with Information Blocking

Laboratory Compliance / Robert Michel

ANY HEALTHCARE PROVIDER DETERMINED TO HAVE COMMITTED “INFORMATION BLOCKING” can now be assessed penalties by federal agencies. On June 24, the federal Department of Health and Human Services (HHS) issued a final rule dealing with information blocking under the authority of the 21st Century Cures Act (Cures Act). The rule describes the disincentives that can

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August 12, 2024, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

In recent years, many of the national retail pharmacy chain operators announced big plans to open primary care clinics. Now, after substantial investments of billions of dollars, those same retail pharmacy chains are unwinding these business lines. This spring, Walmart announced it was shutting down its Walmart Health initiative. That includes closing all 51 of

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What’s a Big Headwind for Labs? It’s the LDT Rule!

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

EXECUTIVES AT PUBLICLY-TRADED CORPORATIONS AND THE FINANCIAL ANALYSTS WHO COVER THESE COMPANIES like to use the term “headwinds” when describing problems preventing these companies from succeeding. It’s the polite euphemism that acknowledges real-world negatives without calling them by their real names, such as high customer turnover, shrinking market share, and poor economic times. I

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