sample. The bound proteins are then vaporized with a laser and ionized for analysis in a mass spectrometer. Patterns of the masses of the various proteins in a sample, rather than actual protein identifications, are produced by SELDI analysis. These mass spectral patterns are used to differentiate patient samples from one another, such as to distinguish diseased from normal samples.

Surrogate endpoint—a biomarker that is intended to substitute for a clinical endpoint in a therapeutic clinical trial and is expected to predict clinical benefit (or harm or lack of benefit or harm) based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence.

Trastuzumab—see HER2.

Validation—the process of assessing the assay or measurement performance characteristics.

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