HalioDx helps your clinical development team to discover and validate new biomarkers by providing a comprehensive analysis of key elements of the immune contexture, in condition of use of your drug, in the targeted indication during your exploratory work.
When a biomarker is identified as potentially clinically relevant, HalioDx is your partner of choice to start a feasibility work and to develop a Clinical Trial Assay (CTA) under Design Control.
Within its 2 CLIA laboratories HalioDx can test patients’ samples using validated CTAs during the clinical phases.
As a next step, if applicable, HalioDx will develop a single site PMA leveraging its IVD Assay Development capabilities & expertise.
HalioDx provides flexible framework for IVD assay development for diagnostics and pharma companies, technology providers and clinical labs. Our offer is an integrated approach to IVD markets and covers contract development, manufacturing & supply, life cycle management and commercialization.
We integrate all essentials requirements in our project core teams:
Multiple registrations & launches have been successfully achieved these past years demonstrating superior quality of services.