Loading
Leica's antibodies for staining the oestrogen receptor (clone 6F11) and progesterone receptor (clone 16) in breast cancer tissue, including ready-to-use versions for its BOND stainers.
FDA 510(k) clearances under 21 CFR 864.1860 (class II), from the openFDA database: oestrogen receptor clone 6F11, first as Vision Biosystems (K060227, 25 May 2006), then Leica Biosystems Newcastle (K122556, 19 May 2014) and the BOND ready-to-use and Novocastra liquid concentrate (K183100, 7 December 2018); progesterone receptor clone 16, first as Vision Biosystems (K062615, 29 January 2007), then BOND ready-to-use and Novocastra liquid (K171753, 21 July 2017; K183102, 7 December 2018; K193393, 6 March 2020). 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 | 2006 | Oestrogen receptor IHC, clone 6F11 (510(k) K060227) |
| US | 2007 | Progesterone receptor IHC, clone 16 (510(k) K062615) |
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Query for this drug: (TITLE:"Leica Biosystems ER clone 6F11 and PR clone 16 antibodies" OR ABSTRACT:"Leica Biosystems ER clone 6F11 and PR clone 16 antibodies" OR TITLE:"Novocastra, BOND" OR ABSTRACT:"Novocastra, BOND" OR TITLE:"Novocastra ER 6F11" OR ABSTRACT:"Novocastra ER 6F11" OR TITLE:"PR 16" OR ABSTRACT:"PR 16" OR TITLE:"Novocastra PR 16" OR ABSTRACT:"Novocastra PR 16" OR TITLE:"BOND ER 6F11" OR ABSTRACT:"BOND ER 6F11") 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 Leica Biosystems ER clone 6F11 and PR clone 16 antibodies (Novocastra, BOND), not a curated reading list.
Shares Leica Biosystems (Danaher), Immunohistochemistry (IHC) and the tag test.
Shares Breast cancer (all types), HR-positive / HER2-negative breast cancer and the tag test.
Shares Immunohistochemistry (IHC) and the tag test.
Shares Immunohistochemistry (IHC) and the tag test.
Shares Immunohistochemistry (IHC) and the tag test.
Shares Immunohistochemistry (IHC) and the tag test.
Shares Immunohistochemistry (IHC) and the tag test.
Shares Immunohistochemistry (IHC) and the tag test.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/