25,000 sf of Advanced Facilities
Located in the heart of Marseille Immunopôle - Luminy, near research institutions and platforms in immunology, research centers and oncology care, and numerous biotechnology companies, HalioDx has nearly 25,000 sf of advanced facilities, using ISO 13485 & ISO 9001 certified facilities quality management system including:
- A CLIA laboratory (2,200 sf), allowing the company to receive US patients’ samples for Immunoscore® Colon reporting and allowing patients’ specimens testing in the context of clinical trials.
- A R&D and Contract Development laboratory (11,000 sf), using mature design control process, compliant with FDA regulatory requirements and 98/79 EC Directive.
- A cGMP compliant manufacturing unit (8,700 sf).
HalioDx has all of the technology platforms necessary for its operations: immunohistochemistry, digital pathology, high throughput next generation sequencing, single cell, quantitative PCR and nCounter® technology (Nanostring).
Quality & Compliance
HalioDx is certified ISO 13485 (since 2007) as well as ISO 9001 (since 2012).
For Europe, the Quality Management System is also maintained to meet the Medical Device Directive 98/79/EC.
For FDA registration, products are developed, manufactured and controlled as requested by the USA regulation and following cGMP requirements for medical devices.
Accreditations:
CLIA n°99D2131292
CLIA for California n° COS 00800828
CLIA for Maryland n° 2730
CLIA for Pennsylvania n° 35816
