# OnCo record dako-pd-l1-22c3-pharmdx (drug). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/drugs/dako-pd-l1-22c3-pharmdx/>
  a schema:Drug ;
  onco:kind "drug" ;
  schema:identifier "dako-pd-l1-22c3-pharmdx" ;
  schema:name "PD-L1 IHC 22C3 pharmDx"@en ;
  schema:description "The 22C3 pharmDx assay is the PD-L1 stain tied to pembrolizumab since 2015 and the source of the combined positive score (CPS). The cut-off differs by cancer: 1% of tumour cells in lung cancer, CPS 1 in gastric, cervical and head and neck cancer, CPS 10 in oesophageal and triple-negative breast cancer, so one stain is read differently per disease."@en ;
  schema:url <https://onco.cc/drugs/dako-pd-l1-22c3-pharmdx/> ;
  schema:dateModified "2026-09-10"^^xsd:date ;
  schema:citation <https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150013>, <https://www.agilent.com/en/product/pharmdx/pd-l1-ihc-22c3-pharmdx> ;
  onco:status "approved" ;
  onco:tag "test" ;
  onco:modality "PD-L1 immunohistochemistry companion diagnostic assay" ;
  schema:alternateName "PD-L1 IHC 22C3 pharmDx" ;
  onco:approval "US 2015: Companion diagnostic for pembrolizumab in NSCLC (TPS)", "US 2017: Gastric / GEJ adenocarcinoma, CPS ≥1", "US 2019: Head and neck squamous cell carcinoma (CPS ≥1) and oesophageal squamous cell carcinoma (CPS ≥10)", "US 2020: Triple-negative breast cancer, CPS ≥10 (pembrolizumab plus chemotherapy)" ;
  onco:cancers <https://onco.cc/cancers/nsclc/>, <https://onco.cc/cancers/gastric/>, <https://onco.cc/cancers/cervical/>, <https://onco.cc/cancers/head-and-neck/>, <https://onco.cc/cancers/esophageal/>, <https://onco.cc/cancers/tnbc/>, <https://onco.cc/cancers/tnbc-metastatic/> ;
  onco:technologies <https://onco.cc/technologies/companion-diagnostic/>, <https://onco.cc/technologies/histopathology-ihc/> ;
  onco:targets <https://onco.cc/targets/pdl1/> ;
  onco:drugs <https://onco.cc/drugs/pembrolizumab/> ;
  onco:companies <https://onco.cc/companies/agilent/> ;
  onco:terms <https://onco.cc/terms/pd-l1-testing/>, <https://onco.cc/terms/cps/>, <https://onco.cc/terms/ihc/> ;
  onco:keyPapers <https://onco.cc/key-papers/paper-rugo-pd-l1-assay-comparison-impassion130-jnci-2021/>, <https://onco.cc/key-papers/paper-sigurjonsdottir-sp142-22c3-tnbc-bcr-2023/> .