{"entity":{"id":"dako-egfr-pharmdx","kind":"drug","name":"EGFR pharmDx","aka":["Dako EGFR pharmDx Kit","DakoCytomation EGFR pharmDx"],"tldr":"The 2004 EGFR protein stain approved with cetuximab for bowel cancer; the FDA database records it as withdrawn in 2024.","summary":"Dako's EGFR pharmDx Kit (Dako is now part of Agilent) was approved on 12 February 2004 (PMA P030044) for cetuximab in colorectal cancer, and a supplement on 27 September 2006 added panitumumab. The FDA PMA database records a withdrawal date of 11 April 2024, although the kit still appeared on the FDA companion diagnostic list when both were read on 3 November 2026.","status":"withdrawn","asOf":"2026-11-03","links":[{"label":"FDA PMA P030044","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030044"},{"label":"FDA: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":[],"cancers":["colorectal"],"sections":[],"technologies":["companion-diagnostic","histopathology-ihc"],"targets":["egfr"],"drugs":["cetuximab","panitumumab"],"companies":["agilent"],"institutions":[],"pathways":[],"terms":["ihc","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["PMA P030044 shows a withdrawal date of 11 April 2024 in the FDA PMA database (read 3 November 2026)."],"brand":"Dako EGFR pharmDx Kit","modality":"Immunohistochemistry companion diagnostic assay (EGFR protein, colorectal tumour tissue)","mechanism":"Immunohistochemistry for EGFR (HER1) protein in colorectal tumour tissue.","approvals":[{"region":"US","year":2004,"indication":"EGFR protein expression for cetuximab in colorectal cancer"},{"region":"US","year":2006,"indication":"EGFR protein expression for panitumumab in colorectal cancer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/dako-egfr-pharmdx/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"},{"id":"histopathology-ihc","kind":"technology","name":"Histopathology & immunohistochemistry","route":"/technologies/histopathology-ihc/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"drug":[{"id":"cetuximab","kind":"drug","name":"Cetuximab","route":"/drugs/cetuximab/"},{"id":"panitumumab","kind":"drug","name":"Panitumumab","route":"/drugs/panitumumab/"}],"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":"ihc","kind":"term","name":"Immunohistochemistry (IHC)","route":"/terms/ihc/"}]}}