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.
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.
A new federal rule has been proposed that will require healthcare providers, including clinical laboratories and pathology groups, to report cyberattacks and ransom paid in a swift timeframe. Also, the FDA’s new LDT federal rule is about to go into effect. The Dark Report further takes a look at an innovation program at an Arizona lab.
Laboratory managers will want to note that The Dark Report itself was targeted by the fraudsters who hit Change Health in a cyberattack. Also, one lab has some innovative methods of combatting the chronic staffing shortage, including hiring college graduates and students.
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
An expert attorney analyzes the most recent cases of EKRA violations, showing how many labs could be in violation themselves. Also, a major cyberattack on Change Healthcare, owned by UnitedHealth Group, creates disruptions to providers around the country. Other news includes a look at the worldwide pathologist shortage.
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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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