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Volume XXXI, No. 12 - September 3, 2024

Assessing the Clinical Service & Revenue Issues of the LDT Rule

Clinical Laboratory, Laboratory Compliance /

BARRING INTERVENTION BY FEDERAL COURTS OR THE U.S. Congress, clinical laboratories will have to comply with the U.S. Food and Drug Administrationā€™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 /

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 /

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 /

CEO SUMMARY: In many major academic centers and the nationā€™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 /

CEO SUMMARY: These are uncertain times for many companies offering a range of digital pathology (DP) products to the nationā€™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 /

THERE ARE NOW TWO LAWSUITS IN TWO DIFFERENT COURTS CHALLENGING THE Food and Drug Administrationā€™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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Uncertainty in the Market for Digital Path Products

TDR Insider /

These are uncertain times for many companies offering a range of digital pathology (DP) products to the nationā€™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 to make

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

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 FTCā€™s Noncompete Rule

Laboratory Compliance, Laboratory Management /

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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