What are the most accurate methods available for HER-2 status assessment?
Tests for HER-2 status measure either gene copy number or presence of protein receptors. The two most widely used technologies and the only two approved by the FDA in the United States are Immunohistochemistry (IHC) and Fluorescence in situ Hybridization (FISH). Chromogenic in situ Hybridization (CISH) and Silver in situ Hybridization (SISH) are two other technologies that measure HER-2 gene copy number. All of these techniques are routinely utilized on formalin-fixed, paraffin-embedded breast tissue.