Halioseek® CR PD-L1/CD8

Combine PD-L1 with CD8 to improve predictive value of PD-L1

Halioseek® CR PD-L1/CD8 is a member of the Immunoscore®‘s assay family. It utilizes standard immunohistochemistry enhanced with advanced image analysis to investigate performance in predicting the response to PD-1/PD-L1 immune checkpoint inhibitors (ICI).

Halioseek® CR PD-L1/CD8 combines on a single slide accurate PD-L1 expression assessment by a pathologist on tumor and immune cells.

Using a proprietary high-resolution image analysis system and bioinformatics pipeline:

  • Computation of CD8+ cells and PD-L1+ density within regions of interest (e.g. core tumor and invasive margin).
  • Assessment of the clustering of CD8+ and PD-L1+ cells.
  • Computation of a proximity index between PD-L1+ and CD8+ cells within regions of interest.
Halioseek® is available and CE-IVD for NSCLC (Non-Small Cell Lung Cancer)  Please visit www.halioseek.com

Scientific data

One mechanism by which cancer tissues limit the host immune response is via upregulation of the PD-L1/ PD-1 pathway (adaptive immune resistance). While PD-L1 expression is correlated to response to ICI’s there are strong debates about the sensitivity, specificity and standardization of PD-L1 immunohistochemistry assays (Adam et al. Ann Pathol. 2016; Scheel et al. Modern Pathology 2016).

Central to the efficacy of immune checkpoint inhibitors (ICI) is the requirement for immune cells to infiltrate into tumors. A significant correlation between the proximity of the PD-1 and PD-L1+ cells and pre-existing CD8+ T cells at the invasive tumor margin with the response to ICI treatment has been demonstrated in melanoma (Tumeh et al. Nature 2014).

In addition the combination of CD8 and PD-L1 biomarkers presence/absence have been proposed to stratify the tumor microenvironment into four different types to orient immunomodulation strategies (Taube JM, Sci Trans Med. 2012 - Sznol M, Clin Cancer Res. 2013; Teng et al. Cancer Res. 2015).

Poster presented at AACR 2017

  • Halioseek™ PD-L1/CD8 is highly correlated to existing commercial PD-L1 assays across a wide range of PD-L1 positive tumors.
  • High overall agreement, sensitivity and specificity with commercial assays approved by the US-FDA ensure equivalent predictive value at 1% and 50% cut-off values.
  • The detection and quantification of CD8-positive cell density on the same slide and CD8/PD-L1 proximity assessment should improve the stratification of NSCLC patients.
  • Clinical studies are ongoing with Halioseek™ PD-L1/CD8.

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