FDA Watch: Labcorp Gets Companion Diagnostic Approval for Advanced Melanoma Test
Company also announces distribution of newly approved Alzheimer’s assay
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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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Lucira Health Secures First EUA for Fully At-Home COVID-19 Testing Kit
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Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification
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Respiratory Panel Tests Flow from EUA Pipeline Ahead of Flu Season
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Saliva COVID-19 Tests Offer Way Around Nasopharyngeal Swab Shortage Bottlenecks
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FDA Offers New Guidance on Validating SARS-CoV-2 Tests in “Non-Laboratory” Settings
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Agency Green Lights First SARS-CoV-2 Tests for Sample Pooling
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Agency Draws a New Line on SARS-CoV-2 Antibody Serology Tests
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Dozens of New COVID-19 Tests Get Emergency Clearance in April
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The FDA’s High-Stakes, High-Risk COVID-19 Serology Test Regulatory Strategy
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