{"entity":{"id":"bond-oracle-her2-ihc","kind":"drug","name":"Bond Oracle HER2 IHC System","aka":[],"tldr":"Leica's HER2 stain for breast cancer, listed by the FDA as a companion to trastuzumab.","summary":"Leica Biosystems' Bond Oracle HER2 IHC System was approved on 18 April 2012 (PMA P090015) and is listed as a companion diagnostic for trastuzumab in breast cancer, detecting HER2 protein overexpression.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P090015","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P090015"},{"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","her2-ihc-3-plus"],"cancers":["breast-her2-positive"],"sections":[],"technologies":["companion-diagnostic","histopathology-ihc"],"targets":["her2"],"drugs":["trastuzumab"],"companies":["leica-biosystems"],"institutions":[],"pathways":[],"terms":["ihc","her2-positive","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Bond Oracle HER2 IHC System","modality":"Immunohistochemistry companion diagnostic assay (HER2 protein, breast tumour tissue)","mechanism":"Immunohistochemistry for HER2 protein in breast tumour tissue.","approvals":[{"region":"US","year":2012,"indication":"HER2 protein overexpression to select trastuzumab in breast cancer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/bond-oracle-her2-ihc/","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":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"biomarker":[{"id":"her2-ihc-3-plus","kind":"biomarker","name":"HER2 IHC 3+ (HER2-positive by immunohistochemistry)","route":"/biomarkers/her2-ihc-3-plus/"}],"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"}],"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":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"company":[{"id":"leica-biosystems","kind":"company","name":"Leica Biosystems (Danaher)","route":"/companies/leica-biosystems/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"},{"id":"her2-positive","kind":"term","name":"HER2-positive (IHC 3+ or ISH-amplified)","route":"/terms/her2-positive/"},{"id":"ihc","kind":"term","name":"Immunohistochemistry (IHC)","route":"/terms/ihc/"}]}}