TAG:
IVD
Machine Learning Poised to Give Clinical Labs New Capabilities
“One of the first questions I ask the laboratory team is ‘do you want to continue to be a factory or do you want to be a change agent in healthcare?’ They all answer that they want contribute to positive change.” —Michael Simpson …
November 13, 2023, Intelligence: Late-Breaking Lab News
Federal regulators recently confirmed that Dec. 4 remains the deadline for public comment on the proposed rule that the federal Food and Drug Administration (FDA) would use to regulate laboratory developed tests (LDTs). This was confirmed during a public webinar for the lab and in vi…
Q3 2023 Financial Reports Show Growth at Labcorp, Quest
Blood brothers Labcorp and Quest Diagnostics showed momentum beyond COVID-19 testing and toward areas that grew base business revenue in their third quarter (Q3) 2023 financial reporting. Company leaders called attention to more partnerships and acquisitions of ho…
Gaining Network Access with Payers Is Often about Geography
EDITOR’S NOTE: Our column, Virchow, is written by anonymous insiders working within the managed…
Two Forces Push for More FDA Oversight of LDTs
CLINICAL AND GENETIC TESTING LABS MAY SUDDENLY FEEL THEMSELVES STUCK IN THE MIDDLE of a yin-yang situation when it comes to laboratory developed tests (LDTs). One force, the U.S. Food and Drug Administrati…
FDA Issues Proposed Rule to Further Regulate LDTs
CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnos…
Is Lab and IVD Consolidation Ready to Hit the Wall?
IN HUMAN HISTORY, ALL ERAS COME TO AN END. The majority of the time, the end of an era is disruptive and a new status quo emerges, with different winners and losers. Today, there is growing evidence that one era in c…
IVD and Lab Consolidation Reduces Choices for Labs
CEO SUMMARY: Since the launch of The Dark Report in 1995, consolidation of hospitals, physician groups, clinical labs, pathology groups, and IVD manufacturers has been a major trend every year. Toda…
IVD Companies Launch New Assays, Analyzers, Automation
Steep declines in SARS-CoV-2 test revenue were reported by the top in vitro diagnostics (IVD) companies in Q2 2023 earnings compared to a year earli…
2022 Ranking of the World’s Top 12 IVD Corporations
WHILE THE TOP FOUR IN VITRO DIAGNOSTICS (IVD) MANUFACTURERS kept their collective hold on the market compared to 2021, the big surprise was that Thermo Fisher Scientific’s…
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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