FDA Watch: OraSure’s Collection Device for Cobas STI Testing Receives Approval
At-home sample collections can be mailed to a clinical laboratory
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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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The FDA Drops a Bombshell: No More EUA Review of COVID-19 LDTs
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FDA Breaks New Ground by Authorizing SARS-CoV-2 Tests for Sample Pooling
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FDA Warns of False-Positives from Becton Dickinson SARS-CoV-2 Test & Reagents
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New CMS Waivers Dramatically Expand Coverage Rules for COVID-19 Testing
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Nearly 3 in 4 Physicians Say They Can’t Provide Easy & Rapid COVID-19 Testing
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Test-Now, Regulate-Later Strategy Generates Robust Dx Test Pipeline in Record Time
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VITAL Act Would Eliminate FDA Regulation of New Tests During Health Emergencies
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