Precision Medicine

Biomarkers are critical to modern clinical research, enabling the identification of patient subgroups, monitoring of treatment efficacy, and support for precision-targeted therapies.

MICS supports biomarker-driven studies with tailored analytical solutions, combining expert assay selection with coordinated testing and quality-controlled reporting.

We manage biomarker analytics in accordance with GCP and GCLP standards, leveraging validated assays from our partner labs or supporting the development of new test systems where needed.

Our services include NGS-based genomic profiling, pharmacogenetic analysis, and immune marker testing, with flexible integration into early- and late-phase clinical studies.

MICS offers integrated support for companion diagnostic (CDx) programs across the Medicover laboratory network — from early feasibility and assay design to regulatory submission and commercialization.

We manage the full CDx lifecycle, including analytical and clinical validation planning, documentation, and compliance with the EU In Vitro Diagnostic Regulation (IVDR).

Within Medicover’s network of accredited laboratories, we coordinate both IVDR-compliant in-house diagnostic solutions and commercial CE-IVD kit development. In-house tests are established under Article 5(5) IVDR through ISO 15189-accredited clinical labs, enabling flexible and regulated implementation in healthcare settings.

For CE-marked kit development, we work with a designated ISO 13485-certified Medicover laboratory, supporting regulatory-compliant manufacturing, validation, and potential market entry.

Beyond scientific and regulatory oversight, MICS also manages the operational infrastructure for CDx programs, including kit logistics, sample collection, certified transport coordination, and the setup of secure digital portals for result tracking and project transparency.

This end-to-end coordination ensures your companion diagnostics are delivered with the scientific integrity, operational reliability, and regulatory compliance required for success.

Understanding individual genetic variability is essential for optimizing drug safety and efficacy. MICS facilitates pharmacogenetic testing programs by coordinating validated gene panels, including CYP450 and other key metabolism markers, through our certified laboratory partners.

These services can be integrated into clinical trials or routine diagnostic workflows to support personalized medicine strategies.

High-resolution HLA typing is a core capability of the MICS network, supporting applications in transplantation, immunotherapy, vaccine studies, and adverse event monitoring. Using NGS-based genotyping platforms, we provide detailed typing across major loci (e.g. HLA-A, -B, -C, -DRB1, -DQB1, -DPB1) with fast turnaround and full regulatory traceability.