# PD-L1 IHC 28-8 pharmDx

Source: https://onco.cc/drugs/pd-l1-ihc-28-8-pharmdx/  
OnCo record `pd-l1-ihc-28-8-pharmdx` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- 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: US 2015: PD-L1 detection in non-squamous NSCLC (original PMA); US 2020: Companion diagnostic for nivolumab with ipilimumab in NSCLC (tumour-cell staining 1% or more); US 2026: Companion diagnostic for nivolumab in oesophageal squamous cell carcinoma and gastric, GEJ and oesophageal adenocarcinoma (CPS 1 or more)

## Sources

- FDA PMA P150025: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150025
- FDA: List of cleared or approved companion diagnostic devices: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools

## Connected records

- drugs: [Ipilimumab](https://onco.cc/drugs/ipilimumab/), [Nivolumab](https://onco.cc/drugs/nivolumab/), [PD-L1 IHC 22C3 pharmDx](https://onco.cc/drugs/dako-pd-l1-22c3-pharmdx/)
- biomarkers: [PD-L1 CPS (combined positive score)](https://onco.cc/biomarkers/pd-l1-cps/), [PD-L1 TC score (tumour-cell score, SP263 and 28-8)](https://onco.cc/biomarkers/pd-l1-tc-score/)
- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Oesophageal and junctional adenocarcinoma](https://onco.cc/cancers/oesophageal-adenocarcinoma/), [Oesophageal squamous cell carcinoma](https://onco.cc/cancers/oesophageal-squamous-cell-carcinoma/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Histopathology & immunohistochemistry](https://onco.cc/technologies/histopathology-ihc/)
- targets: [PD-L1](https://onco.cc/targets/pdl1/)
- companies: [Agilent Technologies (Dako)](https://onco.cc/companies/agilent/)
- terms: [Combined positive score (CPS)](https://onco.cc/terms/cps/), [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/), [PD-L1 expression testing (22C3, SP142, SP263)](https://onco.cc/terms/pd-l1-testing/), [Tumour proportion score (TPS)](https://onco.cc/terms/tps/)

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