The FDA is coming closer to deciding the regulatory fate of complex genetic testing . . . On February 8, the FDA Office of In Vitro Diagnostic Evaluation and Safety (OIVD) will hold a public meeting on In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) at the Hilton Washington, DC/Gaithersburg Hotel. During the public forum, the OIVD will hear from interested stakeholders, regarding the draft guidance issued late last year, which is intended to provide clarification on the FDA’s approach to regulation of in vitro diagnostic multivariate index assays.

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February 2007 - Table of Contents

LIR February 2007 (full PDF issue)

Lab Industry Follows Pharma Into Direct-to-Consumer Marketing

Lab Execs Map Out Competitive Strategies

Sonic Deviates From Offshore Strategy, Acquires Remaining 18% of CPL

Horizon/LabCorp Deal Ousts Bio-Reference

RedPath Builds on a Convergence of Technology

New Congress to Influence Critical Laboratory, Pathology Issues

Cutting Out the Middle Man? Major Lab Players Target Patients in New Media Campaigns

Spectrum to Use Thomson’s MercuryMD Mobile EHR System

United Will Cover Oncotype DX Testing

Lab Stocks Rose 29% In 2006; Genomic Health Was Best Performer

FDA to Hold Meeting on IVDMIAs