Top Articles

Congress May Soon Act on LDT, IVCT Regulation

Major changes in regulation of LDTs have the attention of many labs, IVD manufacturers

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...

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Florida Laboratory Owner Gets 82-Month Jail Term

Executive-owned labs in two states participated in scheme to defraud Medicare using false claims

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 vi...

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

Who’s at fault? The lab director or Elizabeth Holmes?

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 question...

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Regulatory Update Major CLIA Deficiencies Found at California's COVID-19 Lab Facility

News reports point to a possible double standard in how California regulates its own COVID-19 lab

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 (...

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

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 Ver...

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