{"entity":{"id":"ventana-pd-l1-sp142","kind":"drug","name":"VENTANA PD-L1 (SP142) Assay","aka":[],"tldr":"The PD-L1 stain that decides who can have atezolizumab, scored on immune cells rather than tumour cells in breast cancer.","summary":"Approved 18 May 2016 (PMA P160002) as the first PD-L1 assay linked to atezolizumab, in urothelial carcinoma, and subsequently in non-small-cell lung cancer and, in 2019, as the companion diagnostic for atezolizumab plus nab-paclitaxel in triple-negative breast cancer using an immune-cell threshold of 1% (IMpassion130). SP142 stains fewer tumour cells than 22C3 or SP263, and the Blueprint comparison studies showed it is not interchangeable with them, which is why each drug label names its own assay. The breast cancer indication for atezolizumab was later withdrawn in the US, but the assay remains in use in Europe and for lung cancer.","status":"approved","asOf":"2026-09-10","links":[{"label":"FDA PMA P160002","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160002"}],"tags":["test"],"related":["dako-pd-l1-22c3-pharmdx","ventana-pd-l1-sp263"],"cancers":["urothelial","nsclc","tnbc","tnbc-metastatic"],"sections":[],"technologies":["companion-diagnostic","histopathology-ihc"],"targets":["pdl1"],"drugs":["atezolizumab"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["pd-l1-testing","ihc"],"trials":["impassion130"],"people":[],"bottlenecks":[],"keyPapers":["paper-rugo-pd-l1-assay-comparison-impassion130-jnci-2021","paper-sigurjonsdottir-sp142-22c3-tnbc-bcr-2023"],"journals":[],"dependsOn":[],"notes":["What a result means: 'PD-L1 positive' on this assay refers to immune cells in the tumour; a different assay with a different cut-off may give a different answer, so ask which test was used."],"brand":"VENTANA PD-L1 (SP142)","modality":"PD-L1 immunohistochemistry companion diagnostic assay","mechanism":"Rabbit monoclonal antibody SP142 with OptiView amplification on the BenchMark stainer; scored on tumour cells and on tumour-infiltrating immune cells (IC), the latter being the basis of the breast cancer claim.","approvals":[{"region":"US","year":2016,"indication":"PD-L1 expression to inform atezolizumab treatment in urothelial carcinoma (later NSCLC)"},{"region":"US","year":2019,"indication":"Companion diagnostic for atezolizumab in PD-L1 IC ≥1% triple-negative breast cancer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ventana-pd-l1-sp142/","neighbours":{"drug":[{"id":"atezolizumab","kind":"drug","name":"Atezolizumab","route":"/drugs/atezolizumab/"},{"id":"dako-pd-l1-22c3-pharmdx","kind":"drug","name":"PD-L1 IHC 22C3 pharmDx","route":"/drugs/dako-pd-l1-22c3-pharmdx/"},{"id":"ventana-pd-l1-sp263","kind":"drug","name":"VENTANA PD-L1 (SP263) Assay","route":"/drugs/ventana-pd-l1-sp263/"}],"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"pdl1-high-nsclc","kind":"cancer","name":"PD-L1-high non-small-cell lung cancer without a driver mutation","route":"/cancers/pdl1-high-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/"}],"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/"}],"trial":[{"id":"impassion130","kind":"trial","name":"IMpassion130","route":"/trials/impassion130/"}],"paper":[{"id":"paper-impassion130-n-engl-j-med-2018","kind":"paper","name":"Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer","route":"/key-papers/paper-impassion130-n-engl-j-med-2018/"},{"id":"paper-herbst-impower110-atezolizumab-pd-l1-nejm-2020","kind":"paper","name":"Atezolizumab for first-line treatment of PD-L1-selected patients with NSCLC","route":"/key-papers/paper-herbst-impower110-atezolizumab-pd-l1-nejm-2020/"},{"id":"paper-sigurjonsdottir-sp142-22c3-tnbc-bcr-2023","kind":"paper","name":"Comparison of SP142 and 22C3 PD-L1 assays in a population-based cohort of triple-negative breast cancer patients in the context of their clinically established scoring algorithms","route":"/key-papers/paper-sigurjonsdottir-sp142-22c3-tnbc-bcr-2023/"},{"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/"}],"roadmap":[{"id":"tnbc-roadmap","kind":"roadmap","name":"Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem","route":"/roadmaps/tnbc-roadmap/"}],"idea":[{"id":"idea-tnbc-pd-l1-assay-harmonisation","kind":"idea","name":"Harmonise PD-L1 testing for triple-negative breast cancer around one scored assay, with external quality assurance","route":"/ideas/idea-tnbc-pd-l1-assay-harmonisation/"}],"biomarker":[{"id":"pd-l1-ic-score","kind":"biomarker","name":"PD-L1 IC score (immune-cell score, SP142)","route":"/biomarkers/pd-l1-ic-score/"}]}}