Biomarkers for diagnosis and therapy

In both clinical routine and clinical research, there is an increasing need for identification and development of validated biomarkers permitting early diagnosis and prognosis, personalized treatment decisions, and monitoring of treatment responses. Fraunhofer ITEM’s biomarker laboratory is an integral part of the Clinical Research Center Hannover (CRC Hannover). Located on the top floor, it enables direct access to patient samples from the clinical ward and the phase-I unit. A pneumatic delivery system and dedicated sample elevators connect the laboratory with the clinical units, the biobank, and the Hannover Medical School (MHH).

We work in compliance with GLP and GCLP and have an independent quality assurance unit, as we consider industry standards for biomarker measurement to be an important prerequisite for achieving acceptance of endpoints in clinical trials.

Our staff includes technicians and scientists with long-term experience in biomarker analysis. We have in-depth experience with materials from the lung, such as induced sputum, bronchoalveolar lavage, and exhaled breath. The adaptation of biomarker assays to customer requirements and the development of new methods is our research focus.

Services and expertise in biomarker analysis

We have experience with and access to a broad spectrum of well-characterized human samples from our own patient pool, our biobank, and our cooperation with the Hannover Medical School:

  • Induced sputum
  • Bronchoalveolar lavage
  • Bronchial biopsies and brushes
  • Nasal brushes, scrapings, filters, and lavage
  • Exhaled breath and exhaled particles
  • Skin blister fluid and skin biopsies
  • Peripheral blood


We process and analyze human biospecimens using a broad variety of innovative technologies and methods, including in-vitro disease models using primary cells:

  • ChipCytometry
  • Flow cytometry
  • Cell sorting
  • Immunological and cell-based assays
  • Metabolomics
  • Meso Scale Discovery multiplex platform
  • PCR, gene expression array
  • Immunohistochemistry


Assay development and validation

The use of validated assays is crucial for PK or PD evaluation in clinical trials. Based on extensive experience, we develop and validate novel assays to meet the highest quality criteria under the relevant GCP, GLP, and ICH guidelines.


Examples of validation and assay implementation experience:

  • Validation of ELISA to measure interleukin-8, MCP-1, tumor necrosis factor a, MMP9, and GROa in human bronchoalveolar lavage
  • Measurement of eosinophil shape change using flow cytometry
  • Measurement of CRP in human bronchoalveolar lavage


Dr. Meike Müller
Fraunhofer ITEM
Biomarker Analysis
Phone +49 511 5350-8144
Send an e-mail