Key Competencies
- High quality support in continuation of existing CE mark or obtaining CE mark in compliance with the EU Regulation 2017/745 (MDR) and EU Regulation 2017/246 (IVDR)
- Support in the design, performance and reporting of pre-analytical studies, biological assessments, and clinical research
- Methodological access to biological samples and associated pathological data, including fresh cells and tissues; frozen tissues; formalin fixed paraffine embedded (FFPE) slides and blocks; whole blood, serum, plasma, urine samples; and prospective samples. These samples cover the entire pathological spectrum in humans and animals, and can be extended to matching healthy comparisons
Business Model
HALO has privileged relationships with top European academic partners and serves as interface with these institutions:
- Technical University of Graz
- Department of Pathology of the Medical Faculty of the University of Graz
- Biobank in Graz and associated Biobanks of the European network (BBMRI-ERIC)
- Network of 34 leading European hospitals
- Interdisciplinary Research Institute for Health Law and Science of the Sigmund Freud University of Vienna
HALO serves the following customer groups:
- Medical Devices Companies
- Diagnostic Companies
- Contract Research Organizations (CROs) and Accelerators
- Pharmaceutical Companies
- Universities
Academic Partners
HALO’s academic partners played a leading role in the development of standards as described in sections 6 of the new EU Regulations and have a 5-7 years lead in expertise on any competitor
Graz Biobank includes:
- 11,4 Million FFPE slides
- 5,5 Million FFPE blocks
- Around 1 Million other samples (fresh, frozen, blood, urine, etc.)
- 3 Million matching medical records
- 1 Million matching full sets of patient data
- Entire pathological spectrum in humans and animals
- Seamless access to biological material and data stored by other Austrian Biobanks and by17 full members and 4 observing members of the network of EU Biobanks (BBMRI-ERIC)
- Through existing collaborations direct/indirect access to 63 population-based and 215 clinical-based biobanks world-wide
Operating Model
HALO has adopted a step-wise methodology in full-filing customer needs
