Why Halioseek® PD-L1/CD8?
Halioseek® PD-L1/CD8 is intended for the detection of PD-L1 protein and the concomitant detection of CD8 + cells in Non-Small Cell Lung cancer (NSCLC) tissue.
Halioseek® PD-L1/CD8, as a member of the Immunoscore® family assays, is a standardized
Immunohistochemistry (IHC)-based assay.
In addition, HalioDx provides image and data analysis services allowing standardized quantification of both PD-L1+ and CD8+ cell populations and the assessment of cells clustering as well as a proximity index. These measures aim to help identifying which NSCLC patients may best respond to anti-PD1 or anti-PD-L1 immunotherapies.
Halioseek® PD-L1/CD8 is available as a CE-IVD assay for PD-L1+ cells detection and as an RUO* solution in the Rest of The World through our comprehensive offer integrating HalioDx service laboratory.
* For Research Use Only. Not for use in diagnostic procedures.
Material: One FFPE slide
Assay: PD-L1+ & CD8+ cells detection by immunohistochemistry
Digital pathology: computation of CD8+ & PD-L1+ cell densities
Score & report: clustering of CD8+ & PD-L1+ cells
and CD8+ & PD-L1+ proximity index
Halioseek® PD-L1/CD8 solution consists in two parts:
- Halioseek® PD-L1/CD8 IHC kit includes ready-to-use anti-PD-L1 and anti-CD8 antibodies and controls for IHC dual-staining. The stained slide is directly readable by the pathologist to determine the percentage of PD-L1 positive tumor cells, evaluate the presence of PDL1+ immune cells and of CD8+ cells.
- Image analysis using Halioseek® Analyzer for complementary descriptive information:
- Standardized computation of CD8+ and PD-L1+ cell densities on the same slide
- PD-L1+ and CD8+ cells clustering
- Proximity index between PD-L1+ and CD8+ cells
Halioseek® PD-L1/CD8 is intended to help clinicians defining immunotherapy treatment strategy for patients with NSCLC.
Anti-PD-1/PD-L1 are now established treatments for advanced NSCLC patients; however, PD-L1 predictive value is not optimal. Association of PD-L1 + TC % with the assessment of tumor-infiltrating lymphocytes (TILs) via CD8+ T cells quantification and proximity measurement should improve the selection of patients likely to respond to Immune Checkpoint Inhibitors treatment.
How to Order
Halioseek® PD-L1/CD8 workflow
Supportive data & reference publications PD-L1 & CD8
Performance and capacity to improve NSCLC patient stratification for Immune Checkpoint Inhibitors (ICI) treatments.
- Poster presented at AACR2018 Multi-centric PD-L1 and CD8 IHC assessment in NSCLC using Halioseek® CE-IVD assay
- Poster presented at AACR 2017 A new standardized CD8 and PD-L1 dual assay
- Poster presented at SITC 2017 Halioseek® PD‐L1/CD8 assay is equivalent to other validated IVD assays and can be used by clinicians for therapeutic indications in NSCLC. It allows to quantify CD8 T‐cells infiltration on the same slide and provides additional digital pathology tools which could further improve patients selection for treatment with Immune Checkpoint Inhibitors (ICI). Halioseek® PD‐L1/CD8 could have a higher predictive performance than existing IVD tests and could fill a major gap in the management of ICI administration.
Teng MWL et al.
Classifying Cancers Based on T-cell Infiltration and PD-L1
Cancer Res. 2015
Jun 1;75(11):2139-45. doi: 10.1158/0008-5472.CAN-15-0255
Tumeh PC et al.
PD-1 blockade induces responses by inhibiting adaptive immune resistance
Nov 27;515(7528):568-71. doi: 10.1038/nature13954
Taube JM et al.
Association of PD-1, PD-1 ligands, and other features of the tumor immune microenvironment with response to anti-PD-1 therapy
Clin Cancer Res. 2014
Oct 1;20(19):5064-74. doi: 10.1158/1078-0432.CCR-13-3271
Sznol M, Chen L
Antagonist antibodies to PD-1 and B7-H1 (PD-L1) in the treatment of advanced human cancer
Clin Cancer Res. 2013
Mar 1;19(5):1021-34. doi: 10.1158/1078-0432.CCR-12-2063
Fridman WH et al.
The immune contexture in human tumours: impact on clinical outcome
Nat Rev Cancer. 2012
Mar 15;12(4):298-306. doi: 10.1038/nrc3245