{"entity":{"id":"vysis-alk-break-apart-fish","kind":"drug","name":"Vysis ALK Break Apart FISH Probe Kit","aka":[],"tldr":"The test approved with crizotinib in 2011 to find ALK-rearranged lung cancer, still listed as companion to brigatinib and ensartinib.","summary":"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.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P110012","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110012"},{"label":"FDA: List of cleared or approved companion diagnostic devices","url":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"tags":["test"],"related":["ventana-alk-d5f3-cdx","alk-fusion"],"cancers":["nsclc"],"sections":[],"technologies":["companion-diagnostic","cytogenetics-fish"],"targets":["alk"],"drugs":["crizotinib","brigatinib","ensartinib"],"companies":["abbott"],"institutions":[],"pathways":[],"terms":["fish","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Vysis ALK Break Apart FISH Probe Kit","modality":"FISH companion diagnostic test (ALK rearrangement, lung tumour tissue)","mechanism":"Fluorescence in situ hybridisation with probes either side of the ALK gene: when the two signals split apart, the gene has been rearranged.","approvals":[{"region":"US","year":2011,"indication":"Companion diagnostic for crizotinib in ALK-rearranged NSCLC"},{"region":"US","year":2020,"indication":"Companion diagnostic for brigatinib"},{"region":"US","year":2025,"indication":"Companion diagnostic for ensartinib"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/vysis-alk-break-apart-fish/","neighbours":{"drug":[{"id":"brigatinib","kind":"drug","name":"Brigatinib","route":"/drugs/brigatinib/"},{"id":"crizotinib","kind":"drug","name":"Crizotinib","route":"/drugs/crizotinib/"},{"id":"ensartinib","kind":"drug","name":"Ensartinib","route":"/drugs/ensartinib/"},{"id":"ventana-alk-d5f3-cdx","kind":"drug","name":"VENTANA ALK (D5F3) CDx Assay","route":"/drugs/ventana-alk-d5f3-cdx/"}],"biomarker":[{"id":"alk-fusion","kind":"biomarker","name":"ALK fusion (ALK-positive)","route":"/biomarkers/alk-fusion/"}],"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"},{"id":"cytogenetics-fish","kind":"technology","name":"Cytogenetics and FISH","route":"/technologies/cytogenetics-fish/"}],"target":[{"id":"alk","kind":"target","name":"ALK","route":"/targets/alk/"}],"company":[{"id":"abbott","kind":"company","name":"Abbott Laboratories","route":"/companies/abbott/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"},{"id":"fish","kind":"term","name":"FISH / ISH (in situ hybridisation)","route":"/terms/fish/"}]}}