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The ALK stain for lung cancer, approved as companion to four ALK inhibitors: crizotinib, ceritinib, alectinib and lorlatinib.
Ventana Medical Systems' ALK (D5F3) CDx Assay was approved on 12 June 2015 (PMA P140025) as the companion diagnostic for crizotinib in non-small-cell lung cancer. Supplements added ceritinib (26 May 2017), alectinib (6 November 2017) and lorlatinib (3 March 2021). Ventana is part of Roche.
Immunohistochemistry with the D5F3 antibody, reading ALK protein expression in lung tumour tissue as a stand-in for an ALK rearrangement. Connects to ALK.
| Region | Year | Indication |
|---|---|---|
| US | 2015 | Companion diagnostic for crizotinib in ALK-positive NSCLC |
| US | 2017 | Companion diagnostic for ceritinib and for alectinib |
| US | 2021 | Companion diagnostic for lorlatinib |
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Query for this drug: (TITLE:"VENTANA ALK D5F3 CDx Assay" OR ABSTRACT:"VENTANA ALK D5F3 CDx Assay" OR TITLE:"VENTANA ALK" OR ABSTRACT:"VENTANA ALK" OR TITLE:"D5F3 CDx Assay" OR ABSTRACT:"D5F3 CDx Assay" OR TITLE:"Ventana ALK D5F3 CDx Assay" OR ABSTRACT:"Ventana ALK D5F3 CDx Assay") 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 ALK (D5F3) CDx Assay, not a curated reading list.
Shares Companion diagnostic, Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
Shares Companion diagnostic, Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
Shares Companion diagnostic, Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
Shares Companion diagnostic, Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
Shares Companion diagnostic, Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
Shares Companion diagnostic, Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
Shares Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry, Roche / Genentech and the tag test.
Shares Companion diagnostic, Companion diagnostics, Immunohistochemistry (IHC), Histopathology & immunohistochemistry and the tag test.
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