{"entity":{"id":"ventana-alk-d5f3-cdx","kind":"drug","name":"VENTANA ALK (D5F3) CDx Assay","aka":["Ventana ALK (D5F3) CDx Assay"],"tldr":"The ALK stain for lung cancer, approved as companion to four ALK inhibitors: crizotinib, ceritinib, alectinib and lorlatinib.","summary":"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.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P140025","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140025"},{"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":["vysis-alk-break-apart-fish","alk-fusion"],"cancers":["nsclc"],"sections":[],"technologies":["companion-diagnostic","histopathology-ihc"],"targets":["alk"],"drugs":["crizotinib","ceritinib","alectinib","lorlatinib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["ihc","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"VENTANA ALK (D5F3) CDx Assay","modality":"Immunohistochemistry companion diagnostic assay (ALK protein, lung tumour tissue)","mechanism":"Immunohistochemistry with the D5F3 antibody, reading ALK protein expression in lung tumour tissue as a stand-in for an ALK rearrangement.","approvals":[{"region":"US","year":2015,"indication":"Companion diagnostic for crizotinib in ALK-positive NSCLC"},{"region":"US","year":2017,"indication":"Companion diagnostic for ceritinib and for alectinib"},{"region":"US","year":2021,"indication":"Companion diagnostic for lorlatinib"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ventana-alk-d5f3-cdx/","neighbours":{"drug":[{"id":"alectinib","kind":"drug","name":"Alectinib","route":"/drugs/alectinib/"},{"id":"ceritinib","kind":"drug","name":"Ceritinib","route":"/drugs/ceritinib/"},{"id":"crizotinib","kind":"drug","name":"Crizotinib","route":"/drugs/crizotinib/"},{"id":"lorlatinib","kind":"drug","name":"Lorlatinib","route":"/drugs/lorlatinib/"},{"id":"vysis-alk-break-apart-fish","kind":"drug","name":"Vysis ALK Break Apart FISH Probe Kit","route":"/drugs/vysis-alk-break-apart-fish/"}],"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":"histopathology-ihc","kind":"technology","name":"Histopathology & immunohistochemistry","route":"/technologies/histopathology-ihc/"}],"target":[{"id":"alk","kind":"target","name":"ALK","route":"/targets/alk/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"},{"id":"ihc","kind":"term","name":"Immunohistochemistry (IHC)","route":"/terms/ihc/"}]}}