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ivd/lab informatics
Negotiating Path Contracts with Hospitals, Third Parties
By Robert Michel | From the Volume XXXII, No. 2 – January 27, 2025 Issue
PART THREE OF A SERIES TO HELP ANATOMIC PATHOLOGY GROUPS THRIVE AND PROSPER during these challenging times, The Dark Report presents this third installment in a series that identifies clinical, operational, and financial strategies pathology groups…
Pathologist Asks ChatGPT to Predict LDT Trial Outcome
By Robert Michel | From the Volume XXXII, No. 1 – January 6, 2025 Issue
CEO SUMMARY: On his blog last month, pathologist Bruce Quinn, MD, PhD, published the answers provided by two artificial intelligence chatbots after he asked each to analyze the legal briefs submitted to federal courts in Texas where lab plaintiffs are challenging the FDA’s laboratory de…
Top 10 Lab Stories for 2024 Reflect Important Trends
By Robert Michel | From the Volume XXXI, No. 17 – December 16, 2024 Issue
CEO SUMMARY: Most clinical laboratory managers will agree that the Food and Drug Administration’s (FDA) final rule to regulate laboratory developed tests (LDTs) is the biggest lab industry story for 2024. Every laboratory performing LDTs must now devote money and time to comply with the…
Global IVD Companies Issue Third Quarter 2024 Earnings
By Robert Michel | From the Volume XXXI, No. 16 – November 25, 2024 Issue
HERE IS A SUMMARY OF THE SECOND QUARTER FINANCIAL PERFORMANCE of …
Managing Denials and Appeals of Clinical Lab, Path Claims
By Robert Michel | From the Volume XXXI No. 15 – November 4, 2024 Issue
CEO SUMMARY: Based on a study of denials and appeals involving about 20 million lab test claims, the team at XiFin Inc. presents here their findings. They also provide recommendations on steps labs can take to reduce denials and win a greater proportion of appeals. IN RECENT…
State of Whole Genome Sequencing of Newborns
By Robert Michel | From the Volume XXXI, No. 14 – October 14, 2024 Issue
CEO SUMMARY: Genetic medicine continues to support advances in precision medicine (or personalized medicine, if you prefer). This is true in pediatrics, where several statewide pilot programs—each involving tens of thousands of newborns—are publishing studies that demonstrate how exom…
Global IVD Companies Report Second Quarter 2024 Earnings
By Robert Michel | From the Volume XXXI, No. 13 – September 23, 2024 Issue
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 leade…
Assessing the Clinical Service & Revenue Issues of the LDT Rule
By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue
BARRING INTERVENTION BY FEDERAL COURTS OR THE U.S. Congress, clinical labo…
Clarapath Raises $36 Million for Automated Histology Solution
By Robert Michel | From the Volume XXXI, No. 11 – August 12, 2024 Issue
AS THE HISTOLOGY WORKFORCE STRUGGLES TO KEEP UP WITH RISING CASE DEMAND, Clarapath—a Hawt…
What Labs with LDTs Must Do to Comply with FDA’s LDT Rule
By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue
CEO SUMMARY: Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This com…
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