Clinical laboratories and diagnostics manufacturers have been put on notice that the Food & Drug Administration is tightening the rules for in-house developed lab tests and will require premarket review for new types of DNA tests that combine assays and algorithms to produce results tailored to a specific patient.

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September 25, 2006 - Table of Contents

NIR September 25, 2006 (full PDF issue)

FDA Expands Oversight of ‘Home-Brew’ Lab Tests

CMS Proposes Crosswalks to Set New Lab Fees

Labs Urged to Get Ready for ICD-10 Transition

FDA to Regulate New Types of ‘Home Brew’ DNA Tests

FDA Fines American Red Cross $4.2M for Blood Safety Lapses

Medicare Coverage & Claims Advisory

Medicare to Increase Part B Premium, Begin ‘Means-Testing’