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

The Dark Report

Hospital Lab Outreach: Still a Valuable Asset!

Clinical Laboratory Trends / 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 / 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 / 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 / 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 / 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 / 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 / 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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Why Many Pathologists Are Cautious about Digital Path

Digital Pathology, Laboratory Information Systems, Pathology Trends / Robert Michel

CEO SUMMARY: In many major academic centers and the nation’s largest regional pathology supergroups, use of whole slide images and digital pathology workflow are accepted and established. This is often because of benefits unsupported by a pure return on investment. The clinical gains outweigh the capital costs. But for smaller-sized pathology groups, the capital cost

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Uncertainty in Market for Digital Path Products

Digital Pathology / Robert Michel

CEO SUMMARY: 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

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Unpacking the Surprises in the FDA LDT Rule

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

THERE ARE NOW TWO LAWSUITS IN TWO DIFFERENT COURTS CHALLENGING THE Food and Drug Administration’s Authority to regulate laboratory developed tests (LDTs). The first was filed on May 29, 2024, by the American Clinical Laboratory Association (ACLA). The second was filed on Aug. 19, 2024, by the Association for Molecular Pathology (AMP). However these lawsuits

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