PD-L1 IHC — Dako 28-8 pharmDx clone
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | BIO-PDL1-28-8-CLONE |
|---|---|
| Type | Biomarker |
| Aliases | 28-8Dako 28-8PD-L1 28-8 (Dako pharmDx)PD-L1 28-8 pharmDxPD-L1 ІГХ — клон Dako 28-8 pharmDx |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-CHECKMATE-067-LARKIN-2019 SRC-CHECKMATE-816-FORDE-2022 SRC-NCCN-KIDNEY-2025 SRC-NCCN-MELANOMA-2025 |
Biomarker Facts
| Biomarker type | protein_expression_ihc |
|---|---|
| Measurement | MethodIHC with Dako PD-L1 IHC 28-8 pharmDx companion diagnostic on Autostainer Link 48. Tumor-cell membranous staining quantified as % positive tumor cells (TPS-analogous). Used as: - Companion diagnostic: NSCLC nivolumab post-platinum (TC ≥1% complementary in some labels; TC ≥10% in older monotherapy data). - Complementary diagnostic: melanoma nivolumab / nivo+ipi (CheckMate-067) — TC ≥5% identifies subgroup with stronger mono-therapy response, but combo benefits across all expression levels. - RCC nivo+ipi (CheckMate-214) — TC% reported as stratification marker, NOT a cut-point gate. UnitsTC% (% tumor cells with membranous PD-L1 staining) Typical range
|
| Related biomarkers | BIO-PDL1-EXPRESSION BIO-PDL1-TPS |
Notes
Companion-diagnostic clone-specific entity for nivolumab. 28-8 results are interchangeable with 22C3 / SP263 for tumor-cell-based scoring (Blueprint concordance) but NOT for CPS-based scoring. TRIAL ANCHOR: CheckMate-067 (Larkin et al, NEJM 2015 / 2019 5y update) for melanoma nivo / nivo+ipi; CheckMate-214 (Motzer 2018) for RCC combination — Source stub TBD (flag for source-ingest follow-up).
Used By
No reverse references found in the YAML corpus.