DevicePMAs@therightstef:P160002_S009
Annnotations
{"target":"https://pubannotation.org/docs/sourcedb/DevicePMAs@therightstef/sourceid/P160002_S009","sourcedb":"DevicePMAs@therightstef","sourceid":"P160002_S009","text":"Approval for VENTANA PD L1 (SP142) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD L1 clone SP142. The device is intended for use in the assessment of the programmed death-ligand 1 (PD-L1) protein in tumor cells and tumor-infiltrating immune cells in the formalin-fixed, paraffin-embedded (FFPE) tissues indicated below stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a VENTANA BenchMark ULTRA instrument. Determination of PD-L1 status is indication-specific, and evaluation is based on either the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity or the percentage of PD-L1 expressing tumor cells (% TC) of any intensity. VENTANA PD-L1 (SP142) Assay is indicated as an aid for identifying patients for treatment with the therapies for the respective cutoffs listed in Table 1 in accordance with the approved therapeutic product labeling. Table 1. Companion diagnostic indications for the VENTANA PD-L1 (SP142) Assay Indication for use\t Therapy\t Cutoff Urothelial Carcinoma\t TECENTRIQ\t \u003e= 5% ICTriple-Negative Breast Carcinoma (TNBC) TECENTRIQ \u003e= 1% ICPD-L1 expression in \u003e= 50% TC or \u003e= 10% IC determined by VENTANA PD-L1 (SP142) Assay in non-small cell lung cancer (NSCLC) patients may be associated with enhanced overall survival from TECENTRIQ (atezolizumab).This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.\tThis product is intended for in vitro diagnostic (IVD) use.","tracks":[{"project":"PMA_MER","denotations":[{"id":"T1","span":{"begin":0,"end":8},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25425"},{"id":"T2","span":{"begin":35,"end":40},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C60819"},{"id":"T3","span":{"begin":78,"end":83},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C60819"},{"id":"T4","span":{"begin":90,"end":96},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C14264"},{"id":"T5","span":{"begin":119,"end":124},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C37925"},{"id":"T6","span":{"begin":137,"end":143},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C62103"},{"id":"T7","span":{"begin":160,"end":163},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T8","span":{"begin":171,"end":181},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25217"},{"id":"T9","span":{"begin":223,"end":230},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17021"},{"id":"T10","span":{"begin":269,"end":275},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17997"},{"id":"T11","span":{"begin":376,"end":379},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C28954"},{"id":"T12","span":{"begin":384,"end":393},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C16210"},{"id":"T13","span":{"begin":394,"end":397},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C42793"},{"id":"T14","span":{"begin":411,"end":424},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25418"},{"id":"T15","span":{"begin":425,"end":428},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C42793"},{"id":"T16","span":{"begin":442,"end":451},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C47895"},{"id":"T17","span":{"begin":493,"end":499},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25688"},{"id":"T18","span":{"begin":528,"end":538},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25214"},{"id":"T19","span":{"begin":562,"end":572},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C49159"},{"id":"T20","span":{"begin":582,"end":586},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25244"},{"id":"T21","span":{"begin":635,"end":641},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17997"},{"id":"T22","span":{"begin":662,"end":671},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25539"},{"id":"T23","span":{"begin":679,"end":689},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25613"},{"id":"T24","span":{"begin":736,"end":745},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25539"},{"id":"T25","span":{"begin":769,"end":774},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C60819"},{"id":"T26","span":{"begin":827,"end":836},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C15368"},{"id":"T27","span":{"begin":893,"end":898},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48441"},{"id":"T28","span":{"begin":933,"end":944},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25277"},{"id":"T29","span":{"begin":945,"end":952},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C51980"},{"id":"T30","span":{"begin":975,"end":980},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C48441"},{"id":"T31","span":{"begin":994,"end":1004},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25482"},{"id":"T32","span":{"begin":1047,"end":1052},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C60819"},{"id":"T33","span":{"begin":1059,"end":1069},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C41184"},{"id":"T34","span":{"begin":1074,"end":1077},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"},{"id":"T35","span":{"begin":1122,"end":1128},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C47877"},{"id":"T36","span":{"begin":1131,"end":1151},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C4030"},{"id":"T37","span":{"begin":1142,"end":1151},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C2916"},{"id":"T38","span":{"begin":1211,"end":1217},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12971"},{"id":"T39","span":{"begin":1211,"end":1227},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C4872"},{"id":"T40","span":{"begin":1218,"end":1227},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C2916"},{"id":"T41","span":{"begin":1263,"end":1273},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C80488"},{"id":"T42","span":{"begin":1336,"end":1341},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C60819"},{"id":"T43","span":{"begin":1355,"end":1359},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12508"},{"id":"T44","span":{"begin":1360,"end":1364},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C12468"},{"id":"T45","span":{"begin":1389,"end":1392},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C106184"},{"id":"T46","span":{"begin":1396,"end":1406},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25281"},{"id":"T47","span":{"begin":1421,"end":1428},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25605"},{"id":"T48","span":{"begin":1421,"end":1437},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C125201"},{"id":"T49","span":{"begin":1429,"end":1437},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17177"},{"id":"T50","span":{"begin":1454,"end":1466},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C106250"},{"id":"T51","span":{"begin":1473,"end":1480},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C51980"},{"id":"T52","span":{"begin":1518,"end":1529},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C17723"},{"id":"T53","span":{"begin":1533,"end":1544},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C79874"},{"id":"T54","span":{"begin":1585,"end":1593},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25398"},{"id":"T55","span":{"begin":1633,"end":1640},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C51980"},{"id":"T56","span":{"begin":1666,"end":1676},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25482"},{"id":"T57","span":{"begin":1683,"end":1686},"obj":"http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C25340"}],"attributes":[{"subj":"T1","pred":"source","obj":"PMA_MER"},{"subj":"T2","pred":"source","obj":"PMA_MER"},{"subj":"T3","pred":"source","obj":"PMA_MER"},{"subj":"T4","pred":"source","obj":"PMA_MER"},{"subj":"T5","pred":"source","obj":"PMA_MER"},{"subj":"T6","pred":"source","obj":"PMA_MER"},{"subj":"T7","pred":"source","obj":"PMA_MER"},{"subj":"T8","pred":"source","obj":"PMA_MER"},{"subj":"T9","pred":"source","obj":"PMA_MER"},{"subj":"T10","pred":"source","obj":"PMA_MER"},{"subj":"T11","pred":"source","obj":"PMA_MER"},{"subj":"T12","pred":"source","obj":"PMA_MER"},{"subj":"T13","pred":"source","obj":"PMA_MER"},{"subj":"T14","pred":"source","obj":"PMA_MER"},{"subj":"T15","pred":"source","obj":"PMA_MER"},{"subj":"T16","pred":"source","obj":"PMA_MER"},{"subj":"T17","pred":"source","obj":"PMA_MER"},{"subj":"T18","pred":"source","obj":"PMA_MER"},{"subj":"T19","pred":"source","obj":"PMA_MER"},{"subj":"T20","pred":"source","obj":"PMA_MER"},{"subj":"T21","pred":"source","obj":"PMA_MER"},{"subj":"T22","pred":"source","obj":"PMA_MER"},{"subj":"T23","pred":"source","obj":"PMA_MER"},{"subj":"T24","pred":"source","obj":"PMA_MER"},{"subj":"T25","pred":"source","obj":"PMA_MER"},{"subj":"T26","pred":"source","obj":"PMA_MER"},{"subj":"T27","pred":"source","obj":"PMA_MER"},{"subj":"T28","pred":"source","obj":"PMA_MER"},{"subj":"T29","pred":"source","obj":"PMA_MER"},{"subj":"T30","pred":"source","obj":"PMA_MER"},{"subj":"T31","pred":"source","obj":"PMA_MER"},{"subj":"T32","pred":"source","obj":"PMA_MER"},{"subj":"T33","pred":"source","obj":"PMA_MER"},{"subj":"T34","pred":"source","obj":"PMA_MER"},{"subj":"T35","pred":"source","obj":"PMA_MER"},{"subj":"T36","pred":"source","obj":"PMA_MER"},{"subj":"T37","pred":"source","obj":"PMA_MER"},{"subj":"T38","pred":"source","obj":"PMA_MER"},{"subj":"T39","pred":"source","obj":"PMA_MER"},{"subj":"T40","pred":"source","obj":"PMA_MER"},{"subj":"T41","pred":"source","obj":"PMA_MER"},{"subj":"T42","pred":"source","obj":"PMA_MER"},{"subj":"T43","pred":"source","obj":"PMA_MER"},{"subj":"T44","pred":"source","obj":"PMA_MER"},{"subj":"T45","pred":"source","obj":"PMA_MER"},{"subj":"T46","pred":"source","obj":"PMA_MER"},{"subj":"T47","pred":"source","obj":"PMA_MER"},{"subj":"T48","pred":"source","obj":"PMA_MER"},{"subj":"T49","pred":"source","obj":"PMA_MER"},{"subj":"T50","pred":"source","obj":"PMA_MER"},{"subj":"T51","pred":"source","obj":"PMA_MER"},{"subj":"T52","pred":"source","obj":"PMA_MER"},{"subj":"T53","pred":"source","obj":"PMA_MER"},{"subj":"T54","pred":"source","obj":"PMA_MER"},{"subj":"T55","pred":"source","obj":"PMA_MER"},{"subj":"T56","pred":"source","obj":"PMA_MER"},{"subj":"T57","pred":"source","obj":"PMA_MER"}]}],"config":{"attribute types":[{"pred":"source","value type":"selection","values":[{"id":"PMA_MER","color":"#93bfec","default":true}]}]}}