Introduction

The clinical laboratory plays a critical role in modern health care. It is commonly estimated that approximately 70% of all diagnoses are to some extent dependent on a laboratory finding. The clinical laboratory has various roles in the diagnosis and treatment of disease, including determining disease risks, screening for disease, establishing a diagnosis, monitoring of disease progression, and monitoring of response to therapy. Not surprisingly, the size of the market is large. A 2004 report by S.G. Cowen on the global in vitro diagnostics (IVD) industry estimated it to be $26 billion in size, and molecular diagnostics was identified as being among the more rapidly growing areas. Today, molecular testing is used in many areas of the clinical laboratory, including microbiology and virology, analysis of solid and hematologic tumors, inherited disorders, tissue typing, and identity testing (e.g., paternity testing and forensic testing). The growth has occurred rapidly over the last 20 years. In this chapter we examine the principal issues surrounding the integration of molecular testing into the clinical laboratory environment.

Biomarkers in Drug Development: A Handbook of Practice, Application, and Strategy, Edited by Michael R. Bleavins, Claudio Carini, Malle Jurima-Romet, and Ramin Rahbari Copyright © 2010 John Wiley & Sons, Inc.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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