{"entity":{"id":"dako-er-pr-ihc","kind":"drug","name":"Agilent (Dako) ER and PR immunohistochemistry: ER/PR pharmDx, ER clone EP1, PR clones PgR 636 and PgR 1294","aka":["ER/PR pharmDx","Dako ER EP1","Dako PgR 636","Dako PgR 1294","FLEX ER EP1","FLEX PgR 636"],"tldr":"Dako's antibodies and kit for staining the oestrogen and progesterone receptors in breast cancer tissue, cleared by the FDA between 2002 and 2017; Dako is now part of Agilent.","summary":"FDA 510(k) clearances under 21 CFR 864.1860 (class II), from the openFDA database: Dako monoclonal mouse anti-human progesterone receptor, clone PgR 636 (K020023, 28 February 2002); DakoCytomation ER/PR pharmDx kit (K042884, 15 February 2005); monoclonal rabbit anti-human oestrogen receptor alpha, clone SP1 (K081286, 8 May 2009); monoclonal rabbit anti-human oestrogen receptor alpha, clone EP1 (K120663, 12 February 2013); PgR 636 ready-to-use for the Autostainer Link (K130861, 9 December 2013); and for the Dako Omnis platform, ER alpha clone EP1 (K170028) and PR clone PgR 1294 (K170005), both 21 December 2017. An earlier Dako mouse anti-human oestrogen receptor antibody was cleared in 2000 (K993957). The ASCO and College of American Pathologists guideline (Hammond et al., Journal of Clinical Oncology 2010) recommends that oestrogen and progesterone receptor status be determined on all invasive breast cancers and recurrences, and that an assay count as positive if at least 1% of tumour nuclei stain; it found that up to 20% of receptor tests worldwide might be inaccurate.","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA 510(k) K042884","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K042884"},{"label":"FDA 510(k) K120663","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120663"},{"label":"FDA 510(k) K130861","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130861"},{"label":"FDA 510(k) K170028","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170028"},{"label":"FDA 510(k) K170005","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170005"},{"label":"FDA 510(k) K020023","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K020023"}],"tags":["test","ihc-assay"],"related":["er-status","pr-status","ventana-confirm-er-pr","leica-er-pr-ihc","fda-device-databases"],"cancers":["breast-cancer","breast-hr-positive"],"sections":["diagnostics"],"technologies":[],"targets":["estrogen-receptor","pgr"],"drugs":[],"companies":["agilent"],"institutions":[],"pathways":[],"terms":["ihc"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-asco-cap-er-pr-testing-guideline-jco-2010"],"journals":[],"dependsOn":[],"notes":[],"brand":"Dako ER/PR","modality":"Immunohistochemistry assay (oestrogen and progesterone receptor protein, breast tumour tissue)","mechanism":"An antibody that binds the receptor protein is applied to a thin slice of the tumour; a chemical stain makes the cells carrying the receptor visible, and a pathologist reports the share of tumour cells that stain and how strongly.","approvals":[{"region":"US","year":2005,"indication":"ER/PR pharmDx kit (510(k) K042884)"},{"region":"US","year":2013,"indication":"Oestrogen receptor alpha IHC, clone EP1 (510(k) K120663)"},{"region":"US","year":2017,"indication":"Dako Omnis ER EP1 (K170028) and PR PgR 1294 (K170005)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/dako-er-pr-ihc/","neighbours":{"biomarker":[{"id":"er-status","kind":"biomarker","name":"ER status (oestrogen receptor by IHC)","route":"/biomarkers/er-status/"},{"id":"pr-status","kind":"biomarker","name":"PR status (progesterone receptor by IHC)","route":"/biomarkers/pr-status/"}],"drug":[{"id":"leica-er-pr-ihc","kind":"drug","name":"Leica Biosystems ER clone 6F11 and PR clone 16 antibodies (Novocastra, BOND)","route":"/drugs/leica-er-pr-ihc/"},{"id":"ventana-confirm-er-pr","kind":"drug","name":"VENTANA CONFIRM anti-ER (SP1) and anti-PR (1E2) antibodies","route":"/drugs/ventana-confirm-er-pr/"}],"collection":[{"id":"fda-device-databases","kind":"collection","name":"FDA medical device databases (PMA, 510(k), De Novo)","route":"/collections/fda-device-databases/"}],"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"}],"target":[{"id":"estrogen-receptor","kind":"target","name":"Estrogen receptor (ERα)","route":"/targets/estrogen-receptor/"},{"id":"pgr","kind":"target","name":"Progesterone receptor (PGR)","route":"/targets/pgr/"}],"company":[{"id":"agilent","kind":"company","name":"Agilent Technologies (Dako)","route":"/companies/agilent/"}],"term":[{"id":"ihc","kind":"term","name":"Immunohistochemistry (IHC)","route":"/terms/ihc/"}],"paper":[{"id":"paper-asco-cap-er-pr-testing-guideline-jco-2010","kind":"paper","name":"American Society of Clinical Oncology/College Of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer","route":"/key-papers/paper-asco-cap-er-pr-testing-guideline-jco-2010/"}]}}