title: The HER2 CISH pharmDx(™) Kit in the assessment of breast cancer patients for anti-HER2 treatment.
abstract: Testing for amplification of the human EGF receptor 2 (HER2) gene by in situ hybridization is a central principle for the identification of breast cancer patients likely to respond to treatments directed toward HER2. However, its application in clinical routine has been somewhat restricted by the typical use of a visualization system based on fluorescence (FISH), which requires skilled, work-intensive, high-magnification quantitative microscopy. The US FDA has recently approved the HER2 CISH pharmDx™ Kit, which is characterized by employing a chromogenic visualization system that allows quantification of the HER2 gene and centromere 17 reference signals by relatively low-magnification brightfield microscopy. It is indicated as an aid in the assessment of patients for whom Herceptin(®) (trastuzumab) treatment is being considered.
authors.affiliation: Visiopharm A/S, Agern Alle 3, DK-2970 Hoersholm, Denmark.
authors.forename: Niels T
authors.initials: NT
authors.lastname: Foged
authors.forename: Anja
authors.initials: A
authors.lastname: Brügmann
authors.forename: Jan T
authors.initials: JT
authors.lastname: Jørgensen
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000188:drug therapy / Q000235:genetics; D002863:Chromogenic Compounds / Q000737:chemistry; D057069:Diagnostic Test Approval; D005260:Female; D006801:Humans; D017403:In Situ Hybridization; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics* / Q000378:metabolism; D000068878:Trastuzumab
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018931:Antineoplastic Agents, Hormonal; D002863:Chromogenic Compounds; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human