Reliable Business Intelligence News About Clinical Laboratories, Pathology Groups, & Laboratory
Diagnostics Since 1995
The most complete archive of clinical and pathology lab industry news available, including issues from 1997 to the present.
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.
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.
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.
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.
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.
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.
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.
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.
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.
The Dark Report examines all angles of the FDA’s new rule regulating laboratory-developed tests, from an exclusive inside look at the ACLA’s lawsuit against it, to expert attorneys analyzing the details, to how managed care payers regard the new rule. Also in this issue is a look back at how regulators have impacted the clinical lab industry in the past.
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Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
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