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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National Lab Reporter
Keeps You Up-to-Date on Federal & State Laws, Regulations, New Legislation, and Court Cases that Affect Your Diagnostic Lab or Pathology Practice
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Articles and Reports
How to Stay Ahead of Anticipated CLIA Deficiencies
Consultant Nora Hess offers suggestions for clinical labs to navigate these problems
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Four Federal Efforts to Monitor, Including RESULTS Act Progress
Other proposals aim to increase fraud enforcement, temper prior authorization, and modernize CLIA
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FDA Plans to Regulate Lab-Developed Tests Could Increase Time and Cost of Development
In its July 31 notice to Congress, the agency says it would phase in oversight requirements over nine years.
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Labs Finalizing Policies and Procedures Under Patient Access Rule
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FDA Official Defends Plan to Issue Guidance for LDTs
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Texas Lab Must Repay Government $10.6 Million for Illegal Travel Expenses
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Medicare Payments to Hospital Outpatient Labs Showing Huge Shift
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CAP Opposes Proposals to Package Ancillary Services
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Groups Weigh In on PFS; LCDs, 88185, Prostate Biopsy Code Among Concerns
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Labs Advised Not to Delay Release of Test Results Under Patient Access Rule
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