CMS Proposes to Modernize CLIA in Broad Rule
What clinical labs need to know about virtual access, director qualifications, and more
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FDA Watch: Zepto Life Technology Receives FDA Breakthrough Designation for Blood-Based Mold Test
Its FungiFlex assay can make determining the cause of fungal infections vastly more accurate
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New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
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Labs Urged to Coordinate With CDC on Ebola Testing
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Lab Sector Goes to Big Legal Guns in Grapple With FDA Over Test Regulation
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CMS Releases New CLIA-Waived Tests, Billing Codes
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ACLA Issues White Paper Arguing Against FDA Regulation of LDT
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