{"entity":{"id":"ventana-confirm-er-pr","kind":"drug","name":"VENTANA CONFIRM anti-ER (SP1) and anti-PR (1E2) antibodies","aka":["CONFIRM anti-Estrogen Receptor (SP1)","CONFIRM anti-Progesterone Receptor (1E2)","Ventana ER SP1","Ventana PR 1E2"],"tldr":"Ventana's ready-to-use rabbit antibodies for staining the oestrogen and progesterone receptors in breast cancer tissue, cleared by the FDA in 2011 and 2012.","summary":"Ventana Medical Systems' (Roche Diagnostics) CONFIRM anti-Progesterone Receptor (1E2) rabbit monoclonal primary antibody was cleared by the FDA on 16 November 2011 (510(k) K103818, product code MXZ) and its CONFIRM anti-Estrogen Receptor (SP1) rabbit monoclonal primary antibody on 17 December 2012 (K110215, product code MYA), both under 21 CFR 864.1860 (immunohistochemistry reagents, class II). Ventana's earlier antibodies were the ER clone 6F11 (K984567, 1999) and the PgR clone 1A6 (K990618, 1999). 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) K110215","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110215"},{"label":"FDA 510(k) K103818","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103818"}],"tags":["test","ihc-assay"],"related":["er-status","pr-status","dako-er-pr-ihc","leica-er-pr-ihc","fda-device-databases"],"cancers":["breast-cancer","breast-hr-positive"],"sections":["diagnostics"],"technologies":[],"targets":["estrogen-receptor","pgr"],"drugs":[],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["ihc"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-asco-cap-er-pr-testing-guideline-jco-2010"],"journals":[],"dependsOn":[],"notes":[],"brand":"CONFIRM","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":2011,"indication":"Progesterone receptor IHC, clone 1E2 (510(k) K103818)"},{"region":"US","year":2012,"indication":"Oestrogen receptor IHC, clone SP1 (510(k) K110215)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ventana-confirm-er-pr/","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":"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","route":"/drugs/dako-er-pr-ihc/"},{"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/"}],"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":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"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/"}]}}