Companion Diagnostics

From biomarkers to standardized assays

Understanding tumor micro-environment to develop better drugs

  • HalioDx is the only company providing a comprehensive range of immuno-oncology assays: 
    • IHC assays powered by image analysis and digital pathology.
    • Molecular assays on a wide varieties of platforms including NGS, Nanostring platform and QPCR.
    • Proprietary assays with unique performance and clinical impact.
  • Leveraging HalioDx immuno-scoring solutions enable objective and fast decisions to drive your immuno-oncology drug development projects.
  • A proven track record of IVD development to secure your path to the market.


HalioDx expertise from Biomarker Discovery to companion Diagnostic development and commercialization

Pharma

Diagnostics

HalioDx Responsibilities


Biomarker discovery & Design Concept

  • Biomarker selection and evaluation
  • Regulatory strategy
  • Exploratory work (Feasibility)

Assay Development

  • Secure reagents and platform
  • Assay optimization / robustness
  • Assay Prototypes

Proof of Concept

  • Clinical Trial Assay (CTA) development
  • HalioDx CLIA Lab service for patients testing
  • FDA Pre-Sub / IDE

 Investigation Use Only Validation

  • Kit development under Design Control and 21CFR Quality Management System (QMS)
  • Analytical validation

Clinical trial

  • Patients selection
  • Manufacturing site ready for Quality System/GMP inspection
  • Supply of IUO kits
  • IUO Assay used in drug pivotal trial
  • Conduct lab training  and monitoring

PMA submission

  • Preparation and submission of class III PMA file
  • Final Intended Use related to the drug
  • File follow up
  • Launch preparation

Post Launch

  • IVD commercialization
  • Medical Device Reporting
  • Post-approval (Annual) Reports
  • Life Cycle Management

Clinical Trials

HalioDx helps your clinical development team to discover and validate new biomarkers by providing a comprehensive analysis of key elements of the immune contexture with your drug in the targeted indication during your exploratory work.

HalioDx delivers robust data in Phase I/II trial in its Testing Service Lab. The company guarantee maximization of patient biological information utilization and enable seamless decision making processes.

Posters presented by our partners at ASCO 2017:

Biomarker Assay Development

When a biomarker is identified as potentially clinically relevant, HalioDx is your partner of choice to start a feasibility work for a CDx assay prototype development and develop a Clinical Trial Assay (CTA) under Design Control.

Within its CLIA laboratory, HalioDx can test patients’ samples using validated CTAs during the clinical phases.

Characterization of anti‑CD19 chimeric antigen receptor (CAR) T cell‑mediated tumor microenvironment immune gene profile in a multicenter trial (ZUMA‑1) with axica btagene ciloleucel (axi‑cel, KTE‑C19) (J.Galon et al) http://meetinglibrary.asco.org/record/145074/poster

  • Evaluation of Key Immune Pathways Within the Tumor Microenvironment
  • Characterizations of top Immunosign Genes Upregulated in Tumor Tissue Early Post–axi‑cel
  • Characterization of an immune gene signature in the tumor microenvironment early after
    Anti CD19 CAR T cell treatment
  • Co‑upregulation of immune checkpoints within the tumor microenvironment resulted from CAR T Cell treatment
  • Interplay between multiple complementary immune programs deployed by CAR T cells and the innate immunity (IL‑15) within the tumor environment to induce tumor responses

LTX-315, a first in class oncolytic peptide reshapes the tumor microenvironment inducing a local and systemic effect in metastatic tumors: Results from an ongoing study (J.Galon, F.Hermitte et al)

  • Elevation of tumor infiltrating lymphocytes in injected lesions was observed in 14 of 19 (75%) evaluable patients.
  • The HalioDx Immune Gene Expression Signature Immunosign® 21 analysis of LTX-315 treated tumors shows:
    • Clear effect on key genes (effector T cell, Th1 orientation, chemokines, and cytokines) involved in the immune-mediated tumor regression.
    • LTX-315 demonstrates the ability to convert cold tumors hot in cancer patients.

CDx co-Development

At HalioDx we have a significant track record in developing IVD systems combining reagents and software for cancer diagnosis. Our unique organization allows flexibility, speed and accountability to match partner needs.
We integrate in our project core teams all essentials expertise to successfully deliver companion diagnostic tests:

  • Involvement of our IVD experts at inception and all along the project to make sure that all prerequisites are covered and then monitored and aligned with our partner objectives.
  • A mature and efficient Design Control process ISO 13485 & ISO 9001 certified and in compliance with 21 CFR part 820.
  • A milestone based structure enabling transparent projects monitoring by joint steering committee during the development.

Regulatory registration:

Regulatory project planning is among the most important part of a CDx development and HalioDx has gained a significant experience in successful large international IVD registration projects.

Clinical testing:

Our testing team manages large clinical trials projects either at third party clinical sites (Institutions, CRO’s) or internally in compliance with GCLP/GCP practices.

The company is compliant under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for its Marseille-based Reference Laboratory.