Halioseek™ PD-L1/CD8, as a member of the Immunoscore® family assays, is a qualitative Immunohistochemistry (IHC)-based assay intended for the detection of PD-L1 protein in Non-Small Cell Lung cancer (NSCLC) tissue.
In addition, HalioDx offers image and data analysis tools allowing the identification and quantification of CD8+ cells to provide complementary descriptive information (e.g. proximity measurements with PD-L1+ cells).
Halioseek™ PD-L1/CD8 is available worldwide as RUO* solution through our comprehensive offer integrating HalioDx service laboratory.
* For Research Use Only. Not for use in diagnostic procedures.
Utility: Decipher mechanism of response to Immune Checkpoint Inhibitors
Material: FFPE tissue
Target: PD-L1+ & CD8+ cells
Location: Center of the tumor
Technology: Image analysis enhanced Immunohistochemistry
The Halioseek™ PD-L1/CD8 assay is a dual-staining procedure allowing (1) the determination of PD-L1+ tumor cell percentage through pathologist visual analysis and (2) identification and quantification of CD8+ cells through image analysis, to provide complementary descriptive information such as proximity measurements with PD-L1+ cells (HalioDx service*).
The Halioseek™ PD-L1/CD8 assay contains 2 parts:
- Halioseek™ PD-L1/CD8 IHC kit including 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 that are detected
- Image analysis following stained slide scan for complementary descriptive information only performed in HalioDx laboratory (CD8 detection and quantification for proximity measurements)
* Refer to Ordering Information part.
About Non-Small Cell Lung Cancer (NSCLC):
Lung cancer is the most frequent cancer worldwide and is the leading cause of death from cancer. The major histological subtype is Non-Small Cell Lung Cancer (NSCLC) which accounts for around 80% of lung cancer cases. Patients with NSCLC are mostly diagnosed with inoperable locally advanced or metastatic disease.
Immunotherapy, in particular blockade of the PD-1/PD-L1 pathway by immune checkpoint inhibitors (ICI) has recently emerged as an effective therapeutic strategy. Anti-PD-1/PD-L1 are now established agents in the clinical management of advanced NSCLC patients whose tumors express PD-L1 as assessed by IHC.
However, patients with PD-L1 negative tumors can still achieve clinical benefit. Therefore, although PD-L1 positivity enriches for populations with clinical benefit, the selection of patients can be further improved with additional markers (Topalian, S. L. et al. Nat. Rev. Cancer 2016). In particular, the presence of tumor-infiltrating lymphocytes (TILs), which are known to play a crucial role in cellular immune response to cancer, could also be predictive of the response to ICIs.
The presence of lymphocytes within the tumor microenvironment is associated with improved survival in a wide range of cancers including NSCLC (Fridman, W. H. et al. Nat. Rev. Cancer, 2012). In particular, the density of tumor-infiltrating CD8+ T cells has been consistently associated with a better prognosis. Expression of programmed cell death-ligand (PD-L1) is a known mechanism whereby tumor cells can escape immune surveillance. PD-L1 can be constitutively expressed in those cells through oncogenic signaling pathways or it can be induced in response to IFN-gamma released by activated T cells (Pardoll, D. M. Nat. Rev. Cancer, 2012).
Based on PD-L1 status and the presence or absence of tumor-infiltrating lymphocytes (TILs), a classification of tumors into four groups has been proposed (Taube, J. M. et al. Clin. Cancer Res., 2014, Sznol et al. Clin. Cancer Res., 2013 & Teng, M. W. L. et al. Cancer Res., 2015). This classification is more helpful than PD-L1 positivity alone to understand the mechanisms of cancer escape from immune surveillance and to determine the potential for response to PD-1/PD-L1 blockade therapy or to new immunotherapeutic approaches.
In addition to their co-presence, the proximity of PD-L1+ cells and CD8+ T cells in the tumor microenvironment has been shown to be significantly correlated with response to Immune Checkpoint Inhibitors (ICI) treatment in melanoma (Tumeh, P. C. et al. Nature, 2014). Determination of this relative proximity, as evidence of a physical interaction between PD-L1+ and CD8+ cells, might provide complementary information to use in conjunction with the four type-tumor microenvironment classification.
Standardized and validated workflow adapted to your laboratory set-up
* Image analysis from stained slides ** Image analysis from scanned images
Depending on your laboratory equipment Halioseek™ PD-L1/CD8 is available:
- As a full service process (performed in HalioDx laboratories)
- Or through a standardized and validated workflow allowing you to perform the Immunohistochemistry step using Halioseek™ PD-L1/CD8 Kit for a direct PD-L1+ tumor cells assessment. It requires you to send either stained slides or images to HalioDx Service Laboratory for Image analysis and result reporting.
The test is currently available as a RUO (Research Use Only) solution Worldwide. Not for use in diagnostic procedures.
Interested in ordering Halioseek™ PD-L1/CD8?
Please download documentation making your selection in the table below between Full Service, Digital Pathology Service from stained Slides (DPS Service) and Digital Pathology Service from scanned Images (DPI Service).
|Full Service||DPS Service||DPI Service|
|Immunohistochemistry using |
Halioseek™ PD-L1/CD8 Kit
|HalioDx Lab||Your Pathology Lab||Your Pathology Lab|
|Scanning||HalioDx Lab||HalioDx Lab||Your Pathology Lab|
|Image analysis||HalioDx Lab||HalioDx Lab||HalioDx Lab|
|Provided by the pathology lab |
|FFPE blocks or |
2 unstained slides
|Slides stained with |
Halioseek™ PD-L1/CD8 Kit
|Images of the slides|
Supportive data & reference publications
PD-L1 & CD8
Topalian SL et al.
Mechanism-driven biomarkers to guide immune checkpoint blockade in cancer therapy
Nat Rev Cancer. 2016
May;16(5):275-87. doi: 10.1038/nrc.2016.36. Epub 2016 Apr 15.
Adam J et al
PD-L1 expression: An emerging biomarker in non-small cell lung cancer
Ann Pathol. 2016
Jan;36(1):94-102. doi: 10.1016/j.annpat.2015.11.004.
Travis WD et al.
The 2015 World Health Organization Classification of Lung Tumors: Impact of Genetic, Clinical and Radiologic Advances Since the 2004 Classification.
J Thorac Oncol. 2015
Sep;10(9):1243-60. doi: 10.1097/JTO.0000000000000630
Adaptive immune resistance: How cancer protects from immune attack
Cancer Discov. 2015
Sep; 5(9): 915–919. doi: 10.1158/2159-8290.CD-15-0563
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
Ferlay J et al.
Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012
Int J Cancer. 2015
Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210
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
The blockade of immune checkpoints in cancer immunotherapy
Nat Rev Cancer. 2012
Mar 22;12(4):252-64. doi: 10.1038/nrc3239
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