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lab industry
CEO Describes Characteristics Of the Clinical Lab 2.0 Model
CEO SUMMARY: Moving away from volume-based care will not be easy for clinical labs. After all, high volume sustains labs. But labs seeking to transition away from fee-for-service to value-based care must have a seat at the table where decisions are made, said a lab CEO who is part of Proj…
Proposed Bill in Congress Would Regulate LDTs
CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both …
Cautious Optimism Seen At Executive War College
CEO SUMMARY: Among the major themes to emerge from the more than 60 sessions and 100 speakers at this year’s Executive War College on Lab and Pathology Management were the accelerating pace of integrated care, the growth of precision medicine, and use of big data to guide physicians. Ot…
Federal Regulation of LDTs Subject of Proposed Bill
THERE’S A NEW BATTLE over laboratory-developed tests (LDTs) looming on Capitol Hill. In response to the FDA’s draft guidance to regulate LDTs, a bill has been proposed by two members of the house that would shape LDT regulations in different ways than proposed by the FDA. The Diagnostic Accuracy…
Congress Seems Ready to Tackle LDT Regulation
RECENT DEVELOPMENTS SIGNAL THAT THE FIGHT over FDA regulation of laboratory-developed tests (LDTs) is about to intensify. Last month, two Congressional representatives announced a new bill about LDTs that they said was a “discussion draft.” The bill is titled the “Diagnostic Accuracy and Innova…
Aurora Diagnostics Acquires Pathology Groups, Posts Loss
ONE OF THE MORE CURIOUS SITUATIONS IN THE LAB INDUSTRY TODAY is the story of Aurora Diagnostics of Palm Beach Gardens, Fla. Even as it loses money, it continues to acquire pathology group practices. Aurora recently issued its earnings report. For 2016, it disclosed a net loss of $29…
Is CMS Manipulating Data to Increase Medicare Fee Schedule Cuts?
This is an excerpt from a 2,150-word article in the April 3, 2017, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: E…
CMS Extends Reporting of Payer Prices by 60 Days
CEO SUMMARY: Last Thursday, the federal Centers for Medicare and Medicaid Services said it was extending the deadline for certain labs to report their private payer lab test prices by an additional 60 days, until May 30. Statements by CMS officials indicate that either or both the number …
ARUP Laboratories Earns CAP’s ISO 15189 Accreditation
CEO SUMMARY: Being accredited to this internationally recognized standard for quality and competence communicates to clients and prospective clients that one of the nation’s largest clinical labs is committed to the highest standards of quality. Clients already knew about that commitmen…
Lab Acquisitions: LabCorp, Quest, Sonic Do Hospital Lab Deals
This is an excerpt from a 1,021-word article in the March 13, 2017, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: …
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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