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...
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...
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...
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 (...
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...
Don’t Be at the Mercy of the Tumultuous Healthcare Revolution
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