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With LDT Rule Vacated, Labs Await FDA Retort

By Robert Michel | From the Volume XXXII, No. 6 – April 21, 2025 Issue

CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form…

Role of Price Transparency During Path Contract Talks

By Robert Michel | From the Volume XXXII, No. 5 – March 31, 2025 Issue

CEO SUMMARY: Pathology groups have a much better opportunity to turn the tables on payers and other third parties during contract negotiations if they come armed with the data and other information recommended by two well-respected pathology experts…

The Dark Report Acquired by LabX Media Group

By Robert Michel | From the Volume XXXII, No. 4 – March 10, 2025 Issue

CEO SUMMARY: One of the clinical laboratory industry’s longest-running sources of business intelligence, market trends, and management developments has a new owner. LabX Media Group completed its purchase of The Dark Intelligence Group, Inc. (TDIG) on Feb. 28, 2025. This transaction pav…

Mayo Clinic’s Ambitious Digital Pathology Initiative

By Robert Michel | From the Volume XXXII, No. 3 – February 17, 2025 Issue

CEO SUMMARY: It’s the latest example of an academic medical center moving to develop its own digital pathology solutions. This collaboration involves Mayo Clinic, Nvidia, and Aignostics. The three will work together to use digital pathology images and patient data from Mayo Clinic and C…

OIG Issues New Report on Medicare 2023 Lab Spend

By Robert Michel | From the Volume XXXII, No. 2 – January 27, 2025 Issue

CEO SUMMARY: When the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) issued its latest report on Medicare spending in 2023 for clinical laboratory tests, it attracted relatively little attention from the lab industry. Maybe other issues—such a…

Review of Genetic Testing Companies During 2024

By Robert Michel | From the Volume XXXII, No. 1 – January 6, 2025 Issue

CEO SUMMARY: Investors in genetic testing companies are taking it on the chin these days. During 2024, a number of the nation’s largest firms providing genetic test services reported significant losses. Other genetic testing companies are dealing with class action lawsuits claiming that…

Proven Ways to Improve Pathologist Productivity and Compensation

By Robert Michel | From the Volume XXXI, No. 16 – November 25, 2024 Issue

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 serie…

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

By Robert Michel | From the Volume XXXI No. 15 – November 4, 2024 Issue

FOR THE THIRD QUARTER OF 2024 (Q3 2024), both of the nation’s largest publicly traded laboratories—Labcorp…

Four Health Systems Launch ‘Longitude Health’

By Robert Michel | From the Volume XXXI, No. 14 – October 14, 2024 Issue

CEO SUMMARY: For the second time in the past 16 months, respected health systems have taken steps to collaborate specifically to advance value-based care. Longitude Health joins Risant Health as the newest attempt to bring together different health systems and foster collaboration and inn…

Volume XXXII, No. 6 – April 21, 2025

Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.

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