Qualification – the evidentiary process of linking an assay with biological and clinical endpoints that is dependent on the intended application.

Ras gene – a gene encoding for a signal transduction protein that has been found to cause cancer when the gene is altered (mutated). Agents that block its activity may stop the growth of cancer.

Trastuzumab – see Human epidermal growth factor receptor 2.

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