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Volume XXVIII, Number 16 - November 29, 2021

VALID Act vs. VITAL Act: Day of Reckoning for LDTs

Commentary and Opinion by R. Lewis Dark / By

TWO DISTINCTLY DIFFERENT BILLS HAVE SURFACED IN CONGRESS, each with the potential to have substantial impact on how laboratory-developed tests (LDTs) are regulated by agencies of the federal government. One bill even creates a new acronym for the lab industry: IVCT for in vitro clinical tests.  One bill is called the Verifying Accurate Leading-Edge IVCT …

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Congress May Soon Act on LDT, IVCT Regulation

Laboratory Compliance / By

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 tests under CLIA while calling …

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Florida Laboratory Owner Gets 82-Month Jail Term

Laboratory Compliance / By

CEO SUMMARY: Federal prosecutors are sending a clinical lab owner to federal prison for almost eight years. Hopefully, this is a sign that the Department of Justice (DOJ) is ready to use criminal indictments more frequently against lab owners, lab managers, and lab sales reps who violate the federal anti-kickback statute. Morever, this case is …

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In Theranos’ Trial, CLIA Laboratory Director Has a Starring Role

Laboratory Compliance / By

CEO SUMMARY: Most clinical lab directors understand the risks that come with running a CLIA-licensed lab. Such risks are at the forefront of the criminal trial of Elizabeth Holmes, founder of now-defunct Theranos. During the trial, federal prosecutors and defense attorneys questioned four of Theranos’ former lab directors about inaccurate test results and failures to comply …

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Major CLIA Deficiencies Found at California’s COVID-19 Lab Facility

Laboratory Compliance / By

MIGHT THERE BE DIFFERENT STANDARDS IN HOW government regulators enforce CLIA requirements on privately-owned clinical laboratories compared to a government-owned lab?  This question is being asked after the California Department of Public Health (CDPH) finally made public the CLIA inspection report by state officials after they visited the state-owned Valencia Branch Laboratory last winter.  ‘Scathing …

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November 29, 2021 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By

Pathologists interested in ways to automate the various manual steps in the histology laboratory may want to watch the progress of an emerging company. Clarapath of Hawthorne, N.Y., says it is “automating processes around the way tissue is processed onto glass slides via ‘sectioning,’ or cutting a cross-section of the tissue specimen.” The company just …

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Congress May Soon Act on IVCT, LDT Regulation

TDR Insider / By

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 laboratory-developed tests (LDT) regulation and that of other in vitro clinical tests (IVCTs). The VALID …

Congress May Soon Act on IVCT, LDT Regulation Read More »

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