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CDC
Top Stories in 2025 Played Out in Courts, Capitol Hill
CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDAâs final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to incr…
July 14, 2025, Intelligence: Late-Breaking Lab News
Clinical laboratories across the country that have not prepared for the potential of increased measles testing may want to consider doing so. On July 7, The Washington Post reported that US measles cases had reached a 33-year high, based on data collected by the Johns Hopkins Center for…
Lab Industry Fallout from CLIAC Termination
CEO SUMMARY: Some diagnostic lab leaders and anatomic pathology practice owners may not immediately think that the elimination of a federal advisory panel should be on their radar. But the demise of the Clinical Laboratory Improvement Advisory Committee may cost labs by de…
LDT Oversight May Fall to Congress, CLIA
CEO SUMMARY: After a federal court struck down the FDAâs final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…
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,…
Quest Acquires âSelect Assetsâ of Fresenius Medical Care
FRESENIUS MEDICAL CARE AND QUEST DIAGNOSTICS AGREED TO A DEAL in which Quest will provide laboratory testing services for the latterâs dialysis clinics in the United States. Separately, Quest Diagnostics will acquire âselect assetsâ of Spectra Labora…
Labâs Innovation Center Encourages Staff Ideas
CEO SUMMARY: At a time when health plans consider lab testing a commodity, the team at Sonora Quest Laboratories deliberately set out to encourage ideas and innovation from its staff by creating the âInnovation Center of Excellence.â One innovation involves helping health plans and ph…
Examining the Worldwide Pathologist Shortage
CEO SUMMARY: Demand for pathology services is growing faster than the number of pathologists available to meet that demand. This is true for the United States and most other nations. Consequently, efforts are underway to more accurately measure the number of pathologists practicing in eac…
Labs Should Prepare for Arrival of âPerfect Stormâ
CEO SUMMARY: In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming ref…
OIG Reports Its Findings about CDCâs First COVID Test Problems
ONE MAJOR FAILURE BY FEDERAL AGENCIES in the first days of the COVID-19 pandemic was the development and release of an inaccurate and unreliable SARS-CoV-2 test, intended for use by public health labs. This was the finding of the U.S. Department of Health and Human Services (HHS) …
CURRENT ISSUE
Volume XXXII, No. 18 – December 29, 2025
The Dark Report reviews its top 10 stories from 2025, from the vacating of the FDA’s LDT rule to the merger of Waters and Becton Dickinson’s biosciences and diagnostics units. Also, a lab outlines its solution to a shortage of histotechnologists, and another story shows how pathologists can become patients’ partners.
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