Date:- 31 March, 2017

  • HalioDx has developed an assay based on the dual staining of PD-L1 + and CD8+ cells enabled by advanced image analysis tool
  • The assay shows excellent concordance with approved PD-L1 methods
  • Combined analysis of PD-L1+ cells and CD8+ cells is expected to improve predictive performance to identify immune checkpoint inhibitors resistant NSCLC patients
  • Data presented support the potential benefit of using of Halioseek™ PD-L1/CD8 in routine practice and development of a CE-IVD version is ongoing

HalioDx SAS, an immuno-oncology diagnostic company, will present a new set of data confirming the good performance of Halioseek™ PD-L1/CD8 at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington D.C., USA, on Sunday, April 2, 2017 (1:00 – 5:00 PM EST).

PD1/PD-L1 pathway blockade results in a durable clinical response in a fraction of the non-small cell lung cancer (NSCLC) patients. Today, the expression of PD-L1, detected by immunohistochemistry (IHC) at the surface of tumor or tumor-infiltrating immune cells, is used to select patients that may respond to immune checkpoint inhibitors (ICI). However the predictive value of PD-L1 biomarker alone is questioned. In order to better stratify NSCLC patients, HalioDx has developed Halioseek™ PD-L1/CD8[1], a new dual-staining IHC assay of PD-L1+ and CD8+ cells (TILs) present in the tumor microenvironment on a single slide prepared from FFPE tissue.

The Halioseek™ assay, powered by advanced image analysis tool, extracts a full set of information such as CD8+ cell density (cells/mm²), proximity between CD8+ and PD-L1+ cells and finally cluster indexes for CD8+ cells and PD-L1+ cells. Cell-to-cell distances were validated with an independent Digital Pathology (DP) tool. Variability and accuracy were assessed for all parameters using adjacent dual-stained slides on complete tissue sections. The concordance with main IVD approved PD-L1 methods was established on a representative set of 55 NSCLC tumors.

Vincent FERT, CEO of HalioDx comments:Because it measures the two key components of the immune microenvironment with respect to the known ICI mechanism of action, Halioseek™ PD-L1/CD8 has the potential to become the reference assay for precision Immunotherapy. The assay has proven today its accuracy and concordance with main IVD approved PD-L1 methods.”He adds:“This assay is already available to provide our pharmaceutical partners a unique solution for companion diagnostic development and registration. A CE-IVD version is under development to assist clinicians in defining immunotherapy treatment strategy for NSCLC patients in combination with other tumor and patient biological and clinical features.

Poster details:
Session Title: Checkpoints 1
Session Date and Time: Sunday, April 2, 2017 1:00 – 5:00 PM EST
Location: Poster Section 25 / Poster Board Number: 24
The poster will be downloadable on HalioDx website when the session will start.

[1] For Research Use Only. Not for Use in Diagnostic Procedures.



Related Files