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Dako's HER2 gene test, listed as companion to trastuzumab, pertuzumab and trastuzumab emtansine.
The HER2 FISH pharmDx Kit (Dako, now part of Agilent) was approved on 3 May 2005 (PMA P040005) for trastuzumab in breast cancer. Supplements extended it to trastuzumab in gastric and gastro-oesophageal cancer (20 October 2010), pertuzumab in breast cancer (8 June 2012) and trastuzumab emtansine in breast cancer (22 February 2013).
Fluorescence in situ hybridisation measuring HER2 (ERBB2) gene amplification in breast or gastric tumour tissue. Connects to HER2.
| Region | Year | Indication |
|---|---|---|
| US | 2005 | Companion diagnostic for trastuzumab in breast cancer |
| US | 2010 | Trastuzumab in gastric and gastro-oesophageal cancer |
| US | 2012 | Pertuzumab in breast cancer |
| US | 2013 | Trastuzumab emtansine in breast cancer |
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Query for this drug: (TITLE:"HER2 FISH pharmDx Kit" OR ABSTRACT:"HER2 FISH pharmDx Kit" OR TITLE:"HER2 FISH pharmDx" OR ABSTRACT:"HER2 FISH pharmDx") 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 HER2 FISH pharmDx Kit, not a curated reading list.
Shares HER2-positive (IHC 3+ or ISH-amplified), HER2 IHC and ISH companion assays (HercepTest, PATHWAY 4B5, HER2 Dual ISH), Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Cytogenetics and FISH, FISH / ISH (in situ hybridisation), Companion diagnostics and the tag test.
Shares Agilent Technologies (Dako), Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Cytogenetics and FISH, FISH / ISH (in situ hybridisation), Companion diagnostics and the tag test.
Shares Agilent Technologies (Dako), Companion diagnostic, Companion diagnostics and the tag test.
Shares Agilent Technologies (Dako), Companion diagnostic, Companion diagnostics and the tag test.
Shares Agilent Technologies (Dako), Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics, HER2 and the tag test.
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