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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.
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.
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. Connects to Estrogen receptor (ERα) and Progesterone receptor (PGR).
| Region | Year | Indication |
|---|---|---|
| US | 2011 | Progesterone receptor IHC, clone 1E2 (510(k) K103818) |
| US | 2012 | Oestrogen receptor IHC, clone SP1 (510(k) K110215) |
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Query for this drug: (TITLE:"VENTANA CONFIRM anti-ER SP1 and anti-PR 1E2 antibodies" OR ABSTRACT:"VENTANA CONFIRM anti-ER SP1 and anti-PR 1E2 antibodies" OR TITLE:"CONFIRM" OR ABSTRACT:"CONFIRM" OR TITLE:"CONFIRM anti-Estrogen Receptor SP1" OR ABSTRACT:"CONFIRM anti-Estrogen Receptor SP1" OR TITLE:"CONFIRM anti-Progesterone Receptor 1E2" OR ABSTRACT:"CONFIRM anti-Progesterone Receptor 1E2" OR TITLE:"Ventana ER SP1" OR ABSTRACT:"Ventana ER SP1" OR TITLE:"Ventana PR 1E2" OR ABSTRACT:"Ventana PR 1E2") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about VENTANA CONFIRM anti-ER (SP1) and anti-PR (1E2) antibodies, not a curated reading list.
Shares Immunohistochemistry (IHC), Roche / Genentech and the tag test.
Shares Immunohistochemistry (IHC), Roche / Genentech and the tag test.
Shares Immunohistochemistry (IHC), Roche / Genentech and the tag test.
Shares Immunohistochemistry (IHC), Roche / Genentech and the tag test.
Shares Immunohistochemistry (IHC), Roche / Genentech and the tag test.
Shares Immunohistochemistry (IHC), Roche / Genentech and the tag test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Immunohistochemistry (IHC), Roche / Genentech and the tag test.
Shares Immunohistochemistry (IHC), Roche / Genentech and the tag test.
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