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.
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.
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:
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.
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.