{"entity":{"id":"ventana-pten-sp218","kind":"drug","name":"VENTANA PTEN (SP218) RxDx Assay","aka":[],"tldr":"The stain that finds PTEN loss in hormone-sensitive prostate cancer that has spread, selecting men for capivasertib.","summary":"Ventana Medical Systems' (Roche Tissue Diagnostics) PTEN (SP218) RxDx Assay was approved on 12 June 2026 (PMA P250031) as the companion diagnostic for capivasertib in metastatic hormone-sensitive prostate cancer with PTEN protein loss or deficiency.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P250031","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250031"},{"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":["pten-alteration"],"cancers":["prostate-mhspc"],"sections":[],"technologies":["companion-diagnostic","histopathology-ihc"],"targets":["pten"],"drugs":["capivasertib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["ihc","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"VENTANA PTEN (SP218) RxDx Assay","modality":"Immunohistochemistry companion diagnostic assay (PTEN protein, prostate tumour tissue)","mechanism":"Immunohistochemistry with the SP218 antibody for loss of PTEN protein in prostate tumour tissue.","approvals":[{"region":"US","year":2026,"indication":"Companion diagnostic for capivasertib in metastatic hormone-sensitive prostate cancer with PTEN loss"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ventana-pten-sp218/","neighbours":{"biomarker":[{"id":"pten-alteration","kind":"biomarker","name":"PTEN alteration (sequencing) and PTEN loss (IHC)","route":"/biomarkers/pten-alteration/"}],"cancer":[{"id":"prostate-mhspc","kind":"cancer","name":"Metastatic hormone-sensitive prostate cancer","route":"/cancers/prostate-mhspc/"}],"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":"pten","kind":"target","name":"PTEN","route":"/targets/pten/"}],"drug":[{"id":"capivasertib","kind":"drug","name":"Capivasertib","route":"/drugs/capivasertib/"}],"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/"}]}}