CAPABILITIES & COMPLIANCE

Dedicated to the Requirements of In Vitro Diagnostics

29,000 ft2 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 295,000 ft2 of advanced facilitiesadvanced facilities, using ISO 13485 & ISO 9001 certified facilities quality management system including:

    • A CLIA laboratory (2,200 ft2), 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  ft2), using mature design control process, compliant with FDA regulatory requirements and 98/79 EC Directive.
    • A cGMP compliant manufacturing unit (8,700 ft2).

     

    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

    TÜV / ISO 9001-2008 (n°SY 6011 2260 0001)

    TÜV / EN ISO 13485-2012 (n° SY 6011 2255 0001)