Evidence-Based Pathology and Laboratory Medicine in the Molecular Pathology Era: Transition of Tests from the Research Bench into Practice

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Abstract

Molecular pathology presents a particularly difficult challenge to the systematic methodology proposed by evidence-based pathology for the gathering of evidence and classification of such evidence using various evidence level schemes. The rapid developments in the field, complexity of molecular tests, massive quantity of data accrued, and the almost infinite number of analytes addressed by these new technologies render many of the requirements delineated in this chapter – for positive mutation controls, clinical validation, etc. – almost moot. Clearly the genie is out of the bottle, and we have little choice but to move forward thoughtfully, incorporating the approaches we have described when possible, but not adhering to them so rigidly that patients are deprived for too long of their access to these potentially life-saving technologies.

Keywords

Evidence-based pathology Molecular pathology Genomics in pathology ACCE test evaluation Evidence levels analysis 
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Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  1. 1.Ambry GeneticsAliso ViejoUSA

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