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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How to Stay Ahead of Anticipated CLIA Deficiencies
Consultant Nora Hess offers suggestions for clinical labs to navigate these problems
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Ensure Proper Billing of New FDA-Approved CLIA-Waived Tests
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VITAL Act Would Eliminate FDA Regulation of New Tests During Health Emergencies
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Laboratory Developed Tests: The VALID Act is Back
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CLIA: CMS Issues Guidance on How Labs Should Perform Coronavirus Testing
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CLIA: CMS Revises State Operations Manual for Labs
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CLIA: CMS Proposes 20% Fee Increase—and Further Increases Could Follow
From – National Intelligence Report
As if Year 2 of PAMA lab fees wasn’t enough, CMS dished out another dose of agita to the lab industry: CLIA fees will…
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CLIA: After 36 Years, CMS Gives Lab Accreditation a Good Hard Look
From – National Intelligence Report
If you’ve been in the clinical labs business for a while, you probably appreciate the wisdom behind this ancient Chinese curse. 2018 is shaping up to be a very…
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Medicare Reimbursement: CMS Finalizes Controversial PAMA Fee Schedule
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FDA Watch: Agency to Allow DTC Marketing of Genetic Tests without Premarket Approval
From – National Intelligence Report
The FDA’s longstanding policy of restricting direct-to-consumer (DTC) marketing of products without formal premarket approval is well known. But while it always applied to…
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FDA Watch: Agency Moves to Boost CLIA Waiver Transparency
From – National Intelligence Report
The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it…
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