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the dark report
Enjoy the LDT Court Victory, Yet Remain Vigilant
VICTORY IN COURT! FOR AN INDU…
With LDT Rule Vacated, Labs Await FDA Retort
CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form…
BD Will Sell Diagnostics Arm but Retain Vacutainer Brand
LESS THAN TWO MONTHS AFTER ANNOUNCI…
Testing at Pharmacies Enters a Murky Future
CEO SUMMARY: Five years ago, it seemed a solid prediction that retail pharmacies would establish a stronghold in primary care and offer wider access to common diagnostic testing services that clinical laboratories provide. Fast forward to 2025, and the market does not look…
Clinical Lab Test Jargon Could Spur Mistrust among Patients
LITTLE DETAILS CAN MAKE A BIG DIFFERENCE in not only how customers view a clinical laboratory, but also in ensur…
April 21, 2025, Intelligence: Late-Breaking Lab News
The administration of President Donald Trump is calling for a $40 billion cut in funding to the U.S. Department of Health and Human Services (HHS), according to a report in The Washington Post on April 16. This amount would come from HHS discretionary spending,…
Global IVD Companies Issue Fourth Quarter 2024 Earnings
OVERALL, IN VITRO DIAGNOSTICS (IVD) COMPANIES REPORTED A MIXED BAG of financial results for the quarter ending Dec. 31, 2024, with Becton, Dickinson and Company, Abbott Laboratories, and Siemens Healthineers showing the most momentum based on r…
The Dark Report Acquired by LabX Media Group
CEO SUMMARY: One of the clinical laboratory industry’s longest-running sources of business intelligence, market trends, and management developments has a new owner. LabX Media Group completed its purchase of The Dark Intelligence Group, Inc. (TDIG) on Feb. 28, 2025. This transaction pav…
Quest Acquires ‘Select Assets’ of Fresenius Medical Care
FRESENIUS MEDICAL CARE AND QUEST DIAGNOSTICS AGREED TO A DEAL in which Quest will provide laboratory testing services for the latter’s dialysis clinics in the United States. Separately, Quest Diagnostics will acquire “select assets” of Spectra Labora…
Change Health Cyberattack Breaches PHI Here at TDR!
CEO SUMMARY: It was Feb. 21 when cybercriminals attacked Change Healthcare’s claims processing systems. On April 22, UnitedHealth Group issued a statement that PHI for “a substantial proportion of people in America” was breached. We believe the PHI of our employees and T…
CURRENT ISSUE
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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