{"entity":{"id":"pd-l1-ihc-28-8-pharmdx","kind":"drug","name":"PD-L1 IHC 28-8 pharmDx","aka":[],"tldr":"The PD-L1 stain paired with nivolumab: tumour-cell staining of 1% or more for nivolumab with ipilimumab in lung cancer, and a combined positive score of 1 or more in oesophageal and gastric cancers.","summary":"Agilent's (Dako's) PD-L1 IHC 28-8 pharmDx was first approved on 9 October 2015 (PMA P150025) for detecting PD-L1 in non-squamous non-small-cell lung cancer. A supplement on 15 May 2020 made it the companion diagnostic for nivolumab with ipilimumab in non-small-cell lung cancer at tumour-cell staining of 1% or more. A supplement on 1 July 2026 added nivolumab in oesophageal squamous cell carcinoma and in gastric, gastro-oesophageal junction and oesophageal adenocarcinoma at a combined positive score (CPS) of 1 or more. It uses a different antibody from the 22C3 assay that is paired with pembrolizumab.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P150025","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150025"},{"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":["dako-pd-l1-22c3-pharmdx","pd-l1-cps","pd-l1-tc-score"],"cancers":["nsclc","oesophageal-squamous-cell-carcinoma","oesophageal-adenocarcinoma","gastric"],"sections":[],"technologies":["companion-diagnostic","histopathology-ihc"],"targets":["pdl1"],"drugs":["nivolumab","ipilimumab"],"companies":["agilent"],"institutions":[],"pathways":[],"terms":["pd-l1-testing","cps","tps","ihc"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"PD-L1 IHC 28-8 pharmDx","modality":"PD-L1 immunohistochemistry companion diagnostic assay","mechanism":"Immunohistochemistry with the rabbit monoclonal anti-PD-L1 antibody clone 28-8; the FDA approval order defines PD-L1 expression in lung cancer as the percentage of tumour cells with membrane staining at any intensity.","approvals":[{"region":"US","year":2015,"indication":"PD-L1 detection in non-squamous NSCLC (original PMA)"},{"region":"US","year":2020,"indication":"Companion diagnostic for nivolumab with ipilimumab in NSCLC (tumour-cell staining 1% or more)"},{"region":"US","year":2026,"indication":"Companion diagnostic for nivolumab in oesophageal squamous cell carcinoma and gastric, GEJ and oesophageal adenocarcinoma (CPS 1 or more)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/pd-l1-ihc-28-8-pharmdx/","neighbours":{"drug":[{"id":"ipilimumab","kind":"drug","name":"Ipilimumab","route":"/drugs/ipilimumab/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"},{"id":"dako-pd-l1-22c3-pharmdx","kind":"drug","name":"PD-L1 IHC 22C3 pharmDx","route":"/drugs/dako-pd-l1-22c3-pharmdx/"}],"biomarker":[{"id":"pd-l1-cps","kind":"biomarker","name":"PD-L1 CPS (combined positive score)","route":"/biomarkers/pd-l1-cps/"},{"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/"}],"cancer":[{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"oesophageal-adenocarcinoma","kind":"cancer","name":"Oesophageal and junctional adenocarcinoma","route":"/cancers/oesophageal-adenocarcinoma/"},{"id":"oesophageal-squamous-cell-carcinoma","kind":"cancer","name":"Oesophageal squamous cell carcinoma","route":"/cancers/oesophageal-squamous-cell-carcinoma/"}],"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":"agilent","kind":"company","name":"Agilent Technologies (Dako)","route":"/companies/agilent/"}],"term":[{"id":"cps","kind":"term","name":"Combined positive score (CPS)","route":"/terms/cps/"},{"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/"},{"id":"tps","kind":"term","name":"Tumour proportion score (TPS)","route":"/terms/tps/"}]}}