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The test approved with crizotinib in 2011 to find ALK-rearranged lung cancer, still listed as companion to brigatinib and ensartinib.
Abbott Molecular's Vysis ALK Break Apart FISH Probe Kit was approved on 26 August 2011 (PMA P110012) as the companion diagnostic for crizotinib in ALK-rearranged non-small-cell lung cancer. Supplements added brigatinib (22 May 2020) and ensartinib (5 August 2025). The Ventana ALK (D5F3) CDx Assay detects the same alteration as protein by immunohistochemistry.
Fluorescence in situ hybridisation with probes either side of the ALK gene: when the two signals split apart, the gene has been rearranged. Connects to ALK.
| Region | Year | Indication |
|---|---|---|
| US | 2011 | Companion diagnostic for crizotinib in ALK-rearranged NSCLC |
| US | 2020 | Companion diagnostic for brigatinib |
| US | 2025 | Companion diagnostic for ensartinib |
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Query for this drug: (TITLE:"Vysis ALK Break Apart FISH Probe Kit" OR ABSTRACT:"Vysis ALK Break Apart FISH Probe Kit") 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 Vysis ALK Break Apart FISH Probe Kit, not a curated reading list.
Shares Abbott Laboratories, Companion diagnostic, Cytogenetics and FISH, FISH / ISH (in situ hybridisation) and the tag test.
Shares Abbott Laboratories, Companion diagnostic, Cytogenetics and FISH, FISH / ISH (in situ hybridisation) and the tag test.
Shares Abbott Laboratories, Companion diagnostic, Companion diagnostics and the tag test.
Shares Abbott Laboratories, Cytogenetics and FISH, FISH / ISH (in situ hybridisation) and the tag test.
Shares Companion diagnostic, Cytogenetics and FISH, FISH / ISH (in situ hybridisation), Companion diagnostics and the tag test.
Shares Abbott Laboratories, Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics, Non-small-cell lung cancer and the tag test.
Shares Companion diagnostic, Companion diagnostics, Non-small-cell lung cancer and the tag test.
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