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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New FDA Draft Guidance Addresses Companion Diagnostics
From – National Intelligence Report
The U.S. Food and Drug Administration (FDA) released another draft guidance document last week that addresses…
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New FDA Guidances Address NGS and Supporting Variant Databases
From – National Intelligence Report
Promoting flexibility and efficiency, the U.S. Food and Drug Administration (FDA) issued two draft guidances last week addressing oversight of…
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precisionFDA Challenges Support Innovation
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FDA Approves First Liquid Biopsy Companion Diagnostic for Lung Cancer
From – National Intelligence Report
Roche announced last week that the U.S. Food and Drug Administration (FDA) approved the cobas® EGFR Mutation Test v2 “for use with…
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House Appropriations Bill Seeks to Halt FDA Regulation of LDTs
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First Commercial Lab Gets FDA Emergency Clearance for Zika Test
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