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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CMS Proposes Coverage Decision Regarding HIV Screening
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Labs Face Multiple Medicare Threats in New Legislative Year
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Survey Shows Fragmented Environment for FDA Regulation of LDTs
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LDT Regulation Appears to Be Stalled
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23andMe Ordered to Stop Marketing Genome Service
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Justice Department Sets Record in Fraud Recoveries
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Senator Questions ‘Conflicting’ HHS Policies On Patient Access to Lab Data
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CMS Proposes Hepatitis C Screening for Eligible Adults
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