We have built a disease-focused laboratory that is organized around clinical indications and patient needs, rather than specific technologies or test categories.

  • Structured by therapeutic areas (e.g. rare metabolic diseases, immunology, neurology) such as for Lysosomal Storage disorders
  • Combines multiple diagnostic technologies (biochemical, genetic, immunologic) per disease – interdisciplinary approach of several laboratory medicine fields and expertise of employees
  • Offers end-to-end diagnostic algorithms (screening → confirmation → monitoring)
  • Prioritizes clinical utility and interpretation, not just raw results à What to do in screening negative patients; potential differential diagnostics; further lab tests needed to diagnose patient etc

The ARCHIMEDlife central laboratory in Vienna is the backbone of our global diagnostics platform, combining cutting-edge technologies with strict quality standards to deliver precision diagnostics for rare and complex diseases.

We are accredited under ISO 15189, the gold standard for medical laboratories, and operate in full alignment with ISO 27001 and IVDR and ISO 13485 requirements for test development and manufacturing.

Every test performed at ARCHIMEDlife is backed by a system of scientific rigor, digital precision, and unwavering quality — because in rare disease diagnostics, every result matters.

Technologies & Capabilities

Our multidisciplinary lab environment integrates:

  • Clinical Mass Spectrometry (LC-MS/MS):
    High-throughput enzymatic and biomarker analysis
  • Next-Generation Sequencing (NGS) & CE Platforms:
    Custom panels for rare disease confirmation, including single-gene tests, multigene panels, and reflex workflows.
  • Advanced Immunology Platforms:
    Cell-based assays, ELISAs, and functional readouts for ADA (anti-drug antibody) testing, immunogenicity, and immune profiling.

Quality & Compliance

  • ISO 15189: Accredited clinical laboratory since 2017, with regular audits and external quality assessments
  • ISO 13485: Applied to ARCHImedline reagent production and assay development
  • ISO 27001
  • IVDR-Ready: All test procedures and documentation follow current IVDR guidelines
  • CAP/CLIA Certification Roadmap: In progress to support U.S.-based trials and patient programs