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COVID-19
PAMA Test Price Cuts Deferred: It’s a ‘Huge Win’ for Labs
TWO BIPARTISAN VOTES IN THE U.S. HOUSE OF REPRESENTATIVES AND SENATE will save clinical laboratories from another year of deep payment cuts imposed under the Protecting Access to Medicare Act of 2014 (PAMA). “This is a huge win for clinical labs,” s…
Congress May Soon Act on LDT, IVCT Regulation
CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tes…
Congress May Soon Act on IVCT, LDT Regulation
This is an excerpt of a 2,017-word article in the November 29, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Congress is gearing up for a debate on …
It’s Flu Season and COVID-19 Cases Continue
SUBSTANTIAL NUMBERS OF NEW COVID-19 CASES CONTINUE to be reported weekly. No one yet understands whether SARS-CoV-2 may disappear at some future date (as did the 1918 influenza pandemic and SARS outbreak in 2003) or whether SARS-CoV-2 will become endemic and stay with us for years….
New Lab, Pathology Trends at Executive War College 2021
CEO SUMMARY: Hundreds of lab leaders traveled to San Antonio last week for the 27th annual Executive War College on Laboratory and Pathology Management. After almost two years of virtual conference and meetings using Zoom, attendees were ready to gather for a live event, complete with speakers,…
November 8, 2021 Intelligence: Late-Breaking Lab News
Last week, the state of California auto-renewed its controversial COVID-19 testing contract with PerkinElmer to run the Valencia Branch Laboratory. Designed, built, and operated by PerkinElmer, the lab began SARS-CoV-2 testing in the fall of 2020 and immediately was in the news for a range of …
Executive War College to Show New Opportunities for Labs
CEO SUMMARY: Yes, the pandemic continues and hospitals are running short of beds in many communities. At the same time, 225 million Americans are either vaccinated or have some immunity to COVID-19. Based on the early registrations to attend the 27th annual Executive War College, it…
New Class of IVD Firms Wants to Serve POCT in Near-Patient Settings
CEO SUMMARY: Our second installment in this series describes an emerging new clas…
Are Live Lab Industry Conferences Returning?
For several months, many of you have used conversations and email to encourage us to conduct a live Executive War College before the end of 2021. It was because of this support that we arranged a hotel in a state that has supported a return to more normal activities. Thus, our conference will …
Lab Briefs
DOJ Obtains $140 Mil. Settlement in Drug Testing Case Last Friday, the U.S. Department of Justice (DOJ) announced a settlement totaling $136,025,077 with multiple defendants accused of using illegal inducements to encourage physicians to re…
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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