{"entity":{"id":"her2-fish-pharmdx","kind":"drug","name":"HER2 FISH pharmDx Kit","aka":[],"tldr":"Dako's HER2 gene test, listed as companion to trastuzumab, pertuzumab and trastuzumab emtansine.","summary":"The HER2 FISH pharmDx Kit (Dako, now part of Agilent) was approved on 3 May 2005 (PMA P040005) for trastuzumab in breast cancer. Supplements extended it to trastuzumab in gastric and gastro-oesophageal cancer (20 October 2010), pertuzumab in breast cancer (8 June 2012) and trastuzumab emtansine in breast cancer (22 February 2013).","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P040005","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040005"},{"label":"FDA: List of cleared or approved companion diagnostic devices","url":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"tags":["test"],"related":["her2-testing-assays","pathvysion-her2","her2-ish-amplified"],"cancers":["breast-her2-positive","gastric-her2-positive"],"sections":[],"technologies":["companion-diagnostic","cytogenetics-fish"],"targets":["her2"],"drugs":["trastuzumab","pertuzumab","trastuzumab-emtansine"],"companies":["agilent"],"institutions":[],"pathways":[],"terms":["fish","her2-positive","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"HER2 FISH pharmDx","modality":"FISH companion diagnostic test (HER2 gene amplification, tumour tissue)","mechanism":"Fluorescence in situ hybridisation measuring HER2 (ERBB2) gene amplification in breast or gastric tumour tissue.","approvals":[{"region":"US","year":2005,"indication":"Companion diagnostic for trastuzumab in breast cancer"},{"region":"US","year":2010,"indication":"Trastuzumab in gastric and gastro-oesophageal cancer"},{"region":"US","year":2012,"indication":"Pertuzumab in breast cancer"},{"region":"US","year":2013,"indication":"Trastuzumab emtansine in breast cancer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/her2-fish-pharmdx/","neighbours":{"drug":[{"id":"her2-testing-assays","kind":"drug","name":"HER2 IHC and ISH companion assays (HercepTest, PATHWAY 4B5, HER2 Dual ISH)","route":"/drugs/her2-testing-assays/"},{"id":"pathvysion-her2","kind":"drug","name":"PathVysion HER-2 DNA Probe Kit","route":"/drugs/pathvysion-her2/"},{"id":"pertuzumab","kind":"drug","name":"Pertuzumab","route":"/drugs/pertuzumab/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"},{"id":"trastuzumab-emtansine","kind":"drug","name":"Trastuzumab emtansine","route":"/drugs/trastuzumab-emtansine/"}],"biomarker":[{"id":"her2-ish-amplified","kind":"biomarker","name":"HER2 ISH amplified (ERBB2 gene amplification)","route":"/biomarkers/her2-ish-amplified/"}],"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"gastric-her2-positive","kind":"cancer","name":"HER2-positive gastric cancer","route":"/cancers/gastric-her2-positive/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"},{"id":"cytogenetics-fish","kind":"technology","name":"Cytogenetics and FISH","route":"/technologies/cytogenetics-fish/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"company":[{"id":"agilent","kind":"company","name":"Agilent Technologies (Dako)","route":"/companies/agilent/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"},{"id":"fish","kind":"term","name":"FISH / ISH (in situ hybridisation)","route":"/terms/fish/"},{"id":"her2-positive","kind":"term","name":"HER2-positive (IHC 3+ or ISH-amplified)","route":"/terms/her2-positive/"}]}}