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

Volume XXXII, No. 3 - February 17, 2025

Why Labs Should Comply with the FDA’s Final Rule on LDTs

TDR Insider / Robert Michel

On April 29, 2024, the Food and Drug Administration released its final rule on regulation of laboratory developed tests (LDTs). Since then, clinical laboratories have grappled with questions surrounding compliance, while hoping that courts will step in and prevent the rule from taking effect. Now, with a new administration in power and what seem to […]

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Optum Adds Gestalt to Its Digital Diagnostic Suite

Digital Pathology / Robert Michel

CEO SUMMARY: This development signals Optum’s intent to be a player in digital pathology. Its deal with Gestalt Diagnostics adds a pathology solution to Optum’s existing suite of cloud-based services for managing digital images generated by cardiology, radiology, and hematology-oncology. In this rapidly developing market segment, Optum competes against GE Healthcare, Siemens Healthineers, Philips, Sectra,

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Proposed Clinical Laboratory Price Transparency Bill

Laboratory Compliance / Robert Michel

IN DECEMBER, THE CLINICAL LABORATORY PRICE TRANSPARENCY ACT OF 2023 was referred to the U.S. House Ways and Means Subcommittee on Health for final approval. The bill requires labs to disclose information regarding pricing before administering services. The goal is to ensure patients better understand their healthcare costs. Restoring Transparency The bill was originally proposed

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Why Labs Should Comply with FDA’s Final Rule on LDTs

Laboratory Compliance / Robert Michel

CEO SUMMARY: Even as lawsuits challenging the Laboratory Developed Test (LDT rule) issued by the federal Food and Drug Administration (FDA) progress in federal court, clinical labs performing LDTs face an interesting decision. Should they invest the staff time and money to comply with the LDT rule’s Stage One requirements that take effect on May

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Quest Diagnostics, Labcorp Issue Q4 and Full Year 2024 Earnings

Laboratory Management / Robert Michel

LAB ACQUISITIONS IN 2024 WERE A CONTRIBUTING FACTOR TO REVENUE GROWTH at the nation’s two biggest clinical laboratory companies. This was reflected in the fourth quarter and full year 2024 earnings reports issued by Labcorp and Quest Diagnostics. Here are recently reported financial results from these publicly traded laboratories and highlights in diagnostics, acquisitions, and

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Grim Realities Drive Payer Behavior with Lab Test Claims

Managed Care Contracts / Robert Michel

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. Many, if not most,

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February 17, 2025, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Robert Michel

To implement a corporate restructuring, Becton Dickinson (BD) announced on Feb. 5, 2025, that it would proceed to “separate BD’s Biosciences and Diagnostic Solutions business from the rest of BD.” The company plans to complete this action by the end of 2025. Clinical laboratories that buy BD products will be interested to learn that the

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Market Speaks to Pathologists: It’s About Data

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

ONE PRIMARY TREND IN THE U.S. HEALTHCARE SYSTEM over the past 20 years deals with how patient data is created and used. Ongoing advances in information technology and the Internet—now commonly called “the cloud”—have created capabilities for data sharing and data analysis today that were unimagined by experts only a few years ago. Most pathologists

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Mayo Clinic’s Ambitious Digital Pathology Initiative

Digital Pathology / Robert Michel

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 Charité Berlin, a university hospital in Germany, to create and train

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Optum Adds Gestalt to Its Digital Diagnostic Suite

Digital Pathology / Robert Michel

CEO SUMMARY: This development signals Optum’s intent to be a player in digital pathology. Its deal with Gestalt Diagnostics adds a pathology solution to Optum’s existing suite of cloud-based services for managing digital images generated by cardiology, radiology, and hematology-oncology. In this rapidly developing market segment, Optum competes against GE Healthcare, Siemens Healthineers, Philips, Sectra,

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Optum Adds Gestalt to Its Digital Diagnostic Suite Read More »

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