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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FDA Watch: Natera, Valar Labs Receive FDA Clearances for Bladder Cancer Tests
Natera’s assay focuses on the need for adjuvant therapy, while Valar’s test stratifies risk of recurrence
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FDA Watch: New RAPID Coverage Pathway Would Enable Some Lab Tests to Pursue Clearance and Medicare Coverage Simultaneously
FDA-CMS collaboration aims to accelerate Medicare coverage determinations of certain medical devices
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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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Culture-Independent Tests Gain Clinical Traction, Hamper Public Health
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