Principles and pitfalls of diagnostic test development: implications for spectroscopic tissue diagnosis

Diagnostic spectroscopy has the potential to supplant the time-honored "gold standard" of light microscopy and herald an era of in vivo tissue diagnosis. However, the lessons in disease diagnosis learned by pathologists over the years should not be forgotten. This discussion will focus on the basis principles and pitfalls of diagnostic test development, and how they apply to optical spectroscopy tissue diagnosis.