Research

Our research combines clinical human genetics, modern molecular diagnostics, and innovative method development. The goal of our work is the continuous improvement of genetic analyses, the integration of new technologies into routine diagnostics, and close collaboration with academic and industrial partners.

 

In-House Development

A key focus of our work is the development and optimization of modern diagnostic methods. In doing so, we combine scientific innovation with high clinical relevance and diagnostic quality.

Our areas of focus include, among others:

  • Development of new diagnostic assays
  • Optimization of NGS workflows
  • Long-read sequencing
  • Transcriptome sequencing
  • Repeat and methylation analyses
  • Further development of molecular genetic analysis methods
  • Automation of diagnostic processes
  • Liquid biopsy based analysis:
    • Early cancer detection
    • MRD and Recurrence detection
    • Treatment monitoring in cancer patients
    • Disease monitoring in cancer patients
    • Monogenic mosaic disorders

 

Translation into Diagnostics

New technologies and scientific findings are systematically translated into routine diagnostics. Quality, reproducibility, and clinical applicability are central to this process.

This includes:

  • Development and implementation of validation strategies
  • Quality assurance and quality management
  • Implementation of automated processes
  • Integration of new diagnostic methods into routine operations

 

Industry & Research Collaborations

We collaborate with national and international partners from industry and research on the development, evaluation, and implementation of innovative diagnostic methods.

Our collaboration includes, among others:

  • Joint development projects
  • Clinical evaluations and studies
  • Software and bioinformatics solutions
  • Methodological comparative studies
  • Interlaboratory tests and quality assurance programs

Collaboration focus:

  • Assay Development
  • Validation Studies
  • IVDR Readiness
  • Clinical Performance Evaluation
  • Data Analysis & Bioinformatics
  • Translational Research

 

IVDR-Compliant Method Development

Another key focus of our work is the development and implementation of innovative diagnostic methods in compliance with the regulatory requirements of the IVDR.

These include, in particular:

  • Analytical validation
  • Clinical performance evaluation
  • Technical documentation
  • SOP development
  • Risk management
  • PMPF/PMS
  • Laboratory-developed tests (LDTs)

Our goal is the safe, high-quality, and regulatory-compliant integration of new diagnostic methods into clinical practice.

 

Contact

For scientific collaborations, research projects, or inquiries regarding joint development, we look forward to hearing from you.

info.rnd@mgz-muenchen.de