{"entity":{"id":"ventana-pd-l1-sp263","kind":"drug","name":"VENTANA PD-L1 (SP263) Assay","aka":[],"tldr":"The VENTANA SP263 assay is an immunohistochemistry stain that measures PD-L1 on tumour cells. Approved in 2017 alongside durvalumab in bladder cancer, it became the companion test in 2021 for adjuvant atezolizumab in resected lung cancer with PD-L1 on at least 1% of tumour cells, and it agrees closely with 22C3, so laboratories often validate it as a single platform.","summary":"Approved 1 May 2017 (PMA P160046) alongside durvalumab in urothelial carcinoma as a complementary test, SP263 became a companion diagnostic in 2021 for adjuvant atezolizumab in resected stage II-IIIA non-small-cell lung cancer with PD-L1 on at least 1% of tumour cells (IMpower010). In Europe the CE-IVD version carries claims for pembrolizumab, nivolumab and durvalumab across lung, bladder and head and neck cancers, and SP263 is the assay most often shown to be concordant with 22C3 in harmonisation studies. Laboratories frequently validate SP263 as a single platform for several drugs.","status":"approved","asOf":"2026-09-10","links":[{"label":"FDA PMA P160046","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160046"}],"tags":["test"],"related":[],"cancers":["urothelial","nsclc","tnbc"],"sections":[],"technologies":["companion-diagnostic","histopathology-ihc"],"targets":["pdl1"],"drugs":["durvalumab","atezolizumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["pd-l1-testing","ihc"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-rugo-pd-l1-assay-comparison-impassion130-jnci-2021"],"journals":[],"dependsOn":[],"notes":["What a result means: the percentage of tumour cells that stain; higher scores generally predict more benefit from immunotherapy, and thresholds differ by drug and cancer."],"brand":"VENTANA PD-L1 (SP263)","modality":"PD-L1 immunohistochemistry companion diagnostic assay","mechanism":"Rabbit monoclonal antibody SP263 on the BenchMark ULTRA stainer, scored as the percentage of tumour cells with membrane staining (tumour-cell score).","approvals":[{"region":"US","year":2017,"indication":"Complementary PD-L1 assay for durvalumab in urothelial carcinoma"},{"region":"US","year":2021,"indication":"Companion diagnostic for adjuvant atezolizumab in PD-L1 TC ≥1% resected NSCLC"},{"region":"EU","year":2017,"indication":"CE-IVD with claims for several PD-1/PD-L1 antibodies"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ventana-pd-l1-sp263/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"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":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}],"drug":[{"id":"atezolizumab","kind":"drug","name":"Atezolizumab","route":"/drugs/atezolizumab/"},{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"ventana-pd-l1-sp142","kind":"drug","name":"VENTANA PD-L1 (SP142) Assay","route":"/drugs/ventana-pd-l1-sp142/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"term":[{"id":"ihc","kind":"term","name":"Immunohistochemistry (IHC)","route":"/terms/ihc/"},{"id":"pd-l1-testing","kind":"term","name":"PD-L1 expression testing (22C3, SP142, SP263)","route":"/terms/pd-l1-testing/"}],"paper":[{"id":"paper-rugo-pd-l1-assay-comparison-impassion130-jnci-2021","kind":"paper","name":"PD-L1 Immunohistochemistry Assay Comparison in Atezolizumab Plus nab-Paclitaxel-Treated Advanced Triple-Negative Breast Cancer","route":"/key-papers/paper-rugo-pd-l1-assay-comparison-impassion130-jnci-2021/"}],"biomarker":[{"id":"pd-l1-tc-score","kind":"biomarker","name":"PD-L1 TC score (tumour-cell score, SP263 and 28-8)","route":"/biomarkers/pd-l1-tc-score/"},{"id":"pd-l1-tps","kind":"biomarker","name":"PD-L1 TPS (tumour proportion score)","route":"/biomarkers/pd-l1-tps/"}]}}