{"entity":{"id":"ventana-met-sp44","kind":"drug","name":"VENTANA MET (SP44) RxDx Assay","aka":[],"tldr":"The MET protein stain that selects people with lung cancer for telisotuzumab vedotin.","summary":"Ventana Medical Systems' (Roche Tissue Diagnostics) MET (SP44) RxDx Assay was approved on 14 May 2025 (PMA P240037) as the companion diagnostic for telisotuzumab vedotin in non-small-cell lung cancer with high MET protein expression. It measures protein, not a MET gene change, so it selects a different group from tests for MET exon 14 skipping.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P240037","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240037"},{"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":["met-overexpression"],"cancers":["nsclc"],"sections":[],"technologies":["companion-diagnostic","histopathology-ihc"],"targets":["met"],"drugs":["telisotuzumab-vedotin"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["ihc","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"VENTANA MET (SP44) RxDx Assay","modality":"Immunohistochemistry companion diagnostic assay (MET protein, lung tumour tissue)","mechanism":"Immunohistochemistry with the SP44 antibody; the FDA list defines the selecting result as at least 50% of tumour cells with strong (3+) membrane and/or cytoplasmic staining.","approvals":[{"region":"US","year":2025,"indication":"Companion diagnostic for telisotuzumab vedotin in NSCLC with MET protein overexpression"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ventana-met-sp44/","neighbours":{"biomarker":[{"id":"met-overexpression","kind":"biomarker","name":"c-Met protein overexpression (IHC 3+ in >= 50% of tumour cells)","route":"/biomarkers/met-overexpression/"}],"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":"met","kind":"target","name":"MET","route":"/targets/met/"}],"drug":[{"id":"telisotuzumab-vedotin","kind":"drug","name":"Telisotuzumab vedotin","route":"/drugs/telisotuzumab-vedotin/"}],"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/"}]}}