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Issues Archive

The most complete archive of clinical and pathology lab industry news available, including issues from 1997 to the present.

Volume XXXII, No. 1 – January 6, 2025

In this issue:

The Dark Report examines how AI is being used to predict the outcomes of FDA LDT lawsuits. Also, this issue is Part Two of a series about boosting pathology compensation in different settings, including hospitals. Two experienced pathology consultants identify the most effective approaches when negotiating Part A pathology agreements with hospitals and health systems, along with how to use data to bolster these negotiations.

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Volume XXXI, No. 17 – December 16, 2024

In this issue:

This issue examines the top 10 stories from 2024 with the FDA’s LDT rule dominating lab industry headlines, while financial woes dog the entire healthcare sector. Another Top 10 Lab Industry Story centers around the federal government’s final rule on healthcare data interoperability and will help labs that must interface with other providers.

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Volume XXXI, No. 16 – November 25, 2024

In this issue:

Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.

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Volume XXXI No. 15 – November 4, 2024

In this issue:

Quest and Labcorp have been targeted by class action lawsuits involving internet tracking technology. Other lab companies could be next. Also, The Dark Report examines a comprehensive report on denials and appeals of laboratory claims by payers. Finally, Labcorp and Quest show healthy Q3 earnings.

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Volume XXXI, No. 14 – October 14, 2024

In this issue:

For the second time in the past 16 months, respected health systems have taken steps to collaborate specifically to advance value-based care. Also, several statewide pilot programs—each involving tens of thousands of newborns—are publishing studies that demonstrate how exome, whole genome sequencing, and rapid whole genome sequencing can deliver both improved patient outcomes and a return on investment.

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Volume XXXI, No. 13 – September 23, 2024

In this issue:

The Dark Report has visited several companies in Europe to see what innovations they have developed that might be coming to laboratories and pathology groups in the U.S. Also, hospital lab outreach businesses are still valuable commodities in the eyes of the Blood Brothers. In addition, The Dark Report delivers the 2nd quarter earnings reports of the top global IVD companies.

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Volume XXXI, No. 12 – September 3, 2024

In this issue:

This special intelligence briefing—presented in three parts—identifies the factors retarding a faster adoption of digital pathology. Also, how to protect your lab’s proprietary LDTs and assess the financial impact of compliance.

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Volume XXXI, No. 11 – August 12, 2024

In this issue:

This issue identifies current lab trends as experienced by the two Blood Brothers, Labcorp and Quest Diagnostics, and delves into these trends. Also, a new survey highlights consumer healthcare trends that labs should be aware of.

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Volume XXXI, No. 10 – July 22, 2024

In this issue:

An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.

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Volume XXXI, No. 9 – July 1, 2024

In this issue:

The Dark Report examines the new trend of do-it-yourself lab testing, powered by investor-led lab companies that offer lab tests without a doctor’s order. Also, a company is offering its new system that automates microtomy to pathology labs to save time and alleviate the shortage of histotechs, among other benefits the company claims.

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CURRENT ISSUE

Volume XXXII, No. 1 – January 6, 2025

The Dark Report examines how AI is being used to predict the outcomes of FDA LDT lawsuits. Also, this issue is Part Two of a series about boosting pathology compensation in different settings, including hospitals. Two experienced pathology consultants identify the most effective approaches when negotiating Part A pathology agreements with hospitals and health systems, along with how to use data to bolster these negotiations.

See the full table of contents

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