Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

September 2024

Lab Innovators in Europe Have Solutions for the USA

TDR Insider / By 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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It is The Dark Report’s 30th Anniversary!

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

It was 30 years ago, in September 1995, when the first issue of The Dark Report was published and distributed to the clinical laboratory profession. For nearly one-third of a century, our editorial team has worked to bring you the most relevant news, market assessments, and case studies of lab innovations. Many of you have …

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Lab Innovators in Europe Have Solutions for USA

Clinical Laboratory / By Robert Michel

CEO SUMMARY: 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 …

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To access this post, you must purchase The Dark Report.

Hospital Lab Outreach: Still a Valuable Asset!

Clinical Laboratory Trends / By Robert Michel

CEO SUMMARY: Hospital lab administrators everywhere are watching press releases announcing the latest agreement of a major health system selling its laboratory outreach business to one of the billion-dollar lab corporations. The pace of these sales is accelerating. These deals confirm the underlying truth that lab outreach programs do deliver significant operating margins—and capital value—for …

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Hurdles Continue When Labs Request Genetic Test Coverage

Managed Care Contracts / By Virchow

EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed care world. The column aims to help clients of The Dark Report better understand the decisions, policies, and actions of payers as they manage their laboratory networks, establish coverage guidelines, process lab test claims, and audit labs. CLINICAL LABORATORIES BRINGING NEW …

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Global IVD Companies Report Second Quarter 2024 Earnings

In Vitro Diagnostics / By Robert Michel

IN THE SECOND QUARTER OF 2024, in vitro diagnostics (IVD) companies reported solid revenues as well as new tests, analyzers, and automation. Most of the IVD companies boosted diagnostic sales in low single digit amounts. During the earnings calls, financial analysts asked company leaders about growth they may see in 2025. Overall, with the decline …

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September 23, 2024, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

One sign of the financial turmoil associated with the market for genetic tests is the news that all seven independent directors of 23andMe’s board resigned at the same time on Sept. 18. The reason given was that these directors opposed the plan of CEO and co-founder Anne Wojcicki to take the company private. The once …

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Assessing the Clinical Service & Revenue Issues of the LDT Rule

Clinical Laboratory, Laboratory Compliance / By Robert Michel

BARRING INTERVENTION BY FEDERAL COURTS OR THE U.S. Congress, clinical laboratories will have to comply with the U.S. Food and Drug Administration’s (FDA) new final rule regarding laboratory developed tests (LDTs). To do so, many laboratories will need to take a hard look at their current LDT offerings, with an eye toward which ones are …

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Fitting Pathology AI Firms into DP Market Puzzle

Digital Pathology, Pathology Trends / By Robert Michel

CEO SUMMARY: Today, the best-known developers of AI-based algorithms have been in business almost 10 years. During that time, there has been continuous improvement in the digital technologies used in digital scanning and digital image analysis. Despite these improvements, many pathology group practices have yet to make the commitment to acquire and deploy a full …

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Pioneering DP Companies Ended Up Being Acquired

Digital Pathology, Pathology Trends / By Robert Michel

CEO SUMMARY: One reason why the adoption of a full digital pathology solution has lagged behind expectations may be attributed to the fact that four of the pioneering companies did not survive as independent businesses. They were sold and not all the new owners continued investing and developing those DP systems. This was watched by …

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