{"entity":{"id":"vysis-cll-fish","kind":"drug","name":"Vysis CLL FISH Probe Kit","aka":[],"tldr":"The FDA-approved blood test for the 17p deletion in chronic lymphocytic leukaemia, approved alongside venetoclax.","summary":"Abbott Molecular's Vysis CLL FISH Probe Kit was approved on 11 April 2016 (PMA P150041) as the companion diagnostic for venetoclax in B-cell chronic lymphocytic leukaemia with deletion 17p.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P150041","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150041"},{"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":["tp53-del17p"],"cancers":["cll"],"sections":[],"technologies":["companion-diagnostic","cytogenetics-fish"],"targets":["tp53"],"drugs":["venetoclax"],"companies":["abbott"],"institutions":[],"pathways":[],"terms":["fish","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Vysis CLL FISH Probe Kit","modality":"FISH companion diagnostic test (chromosome 17p deletion, blood)","mechanism":"Fluorescence in situ hybridisation on peripheral blood cells to detect deletion of chromosome 17p, the region that carries TP53.","approvals":[{"region":"US","year":2016,"indication":"Companion diagnostic for venetoclax in chronic lymphocytic leukaemia with deletion 17p"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/vysis-cll-fish/","neighbours":{"biomarker":[{"id":"tp53-del17p","kind":"biomarker","name":"TP53 mutation and del(17p)","route":"/biomarkers/tp53-del17p/"}],"cancer":[{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"}],"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":"tp53","kind":"target","name":"TP53","route":"/targets/tp53/"}],"drug":[{"id":"venetoclax","kind":"drug","name":"Venetoclax","route":"/drugs/venetoclax/"}],"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/"}]}}