Top Articles
Global Computer Outage Shows Risk to Clinical Labs
Along with the move to cloud-based computing comes greater risk of disruption and cyberattacks
CEO SUMMARY: Last Friday’s global computer outage was due to a faulty update to a widely used endpoint security software system. The level of disruption worldwide in air travel, commerce, and information processing was unprecedented. This incident highlights that there are risks when a ...
Language in Draft House Bill Directs FDA to Suspend LDT Rule
It is a sign that some members in Congress recognize how FDA’s actions to regulate LDTs can disrupt care
THERE IS AN INTERESTING NEW DEVELOPMENT associated with the regulation of laboratory deve...
2023 Ranking of the World's Top 13 IVD Corporations
BASED ON 2023 DIAGNOSTICS-RELATED REVENUE, four in vitro diagnostics (IVD) manufacturers continued to lead the global IVD market just as they did in 2022. They are: Thermo Fisher Scientific, Inc., Roche Holdings, Abbott Laboratories, and Danaher Corporation. Th...
Labs, Payers Don’t Like Prior Authorization for Genetic Tests
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What Labs with LDTs Must Do to Comply with FDA’s LDT Rule
Compliance with LDT Rule will be time-consuming and costly for majority of LDTs
CEO SUMMARY: Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This com...
Quest Diagnostics Moves to Acquire LifeLabs of Canada
Following deal, U.S.-based Quest, like Labcorp, will own a major national Canadian lab company
QUEST DIAGNOSTICS, ALREADY A CLINICAL LABORATORY BEHEMOTH IN THE U.S., is expanding its Nor...
Invitae’s Troubled Journey: Rise, Fall, and Bankruptcy
Investors poured billions into the genetic testing firm, but the outcome was billions in losses and liquidation
ON MAY 7, THE REMNANTS OF GENETIC TESTING GIANT INVITAE (NYSE: NVTA) were scooped up by ...
What’s a Big Headwind for Labs? It’s the LDT Rule!
EXECUTIVES AT ...
Don’t Be at the Mercy of the Tumultuous Healthcare Revolution
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CURRENT ISSUE
Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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