Fraunhofer ITEM’s biomarker laboratory

Biomarkers for diagnosis and therapy

Privacy warning

With the click on the play button an external video from is loaded and started. Your data is possible transferred and stored to third party. Do not start the video if you disagree. Find more about the youtube privacy statement under the following link:

In both clinical routine and clinical research, there is an increasing need for identification and development of validated biomarkers permitting early disease 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). Not only does the laboratory have direct access to patient samples from the outpatient department and the phase-I unit of the CRC Hannover; a pneumatic delivery system directly connects it with clinical departments, the biobank, and the adjacent Hannover Medical School.

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 fluid, and exhaled breath. Focuses of our research are on the customization of biomarker assays to meet our clients’ special requirements and on the development of new methods.

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 regulatory acceptance of endpoints in clinical trials.

Services and expertise in biomarker analysis

Our expertise


Owing to our own large patient community, our biobank, and our collaboration with the Hannover Medical School, we have experience with and access to a broad spectrum of well-characterized human samples:

  • Induced sputum
  • Bronchoalveolar lavage
  • Bronchial biopsies and brushings
  • Bronchosorption 
  • Nasal specimens (brushings, scrapings, filter paper, and lavage)
  • Exhaled breath and exhaled particles
  • Skin blister fluid and skin biopsies
  • Peripheral blood

Our technologies


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

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

Chip cytometry

Chip-based cell analysis, i.e. chip cytometry, enables iterative staining of cellular markers like in flow cytometry, but in addition allows analyses in stored samples.

Assay development and validation

The use of validated assays is crucial for pharmacokinetic and pharmacodynamic evaluations in clinical trials. Based on our extensive experience, we develop and validate novel assays meeting the highest quality criteria under the relevant GCP, GLP, and ICH guidelines.


Examples from our track record of validation and assay implementation:

  • Validation of ELISA to measure interleukin-8, MCP-1, tumor necrosis factor α, MMP-9, and GROa in human bronchoalveolar lavage fluid
  • Measurement of eosinophil shape change using flow cytometry
  • Measurement of CRP in human bronchoalveolar lavage fluid
Validated assays are crucial for pharmacokinetic and pharmacodynamic evaluations in clinical trials.
© Fraunhofer ITEM
Validated assays are crucial for pharmacokinetic and pharmacodynamic evaluations in clinical trials.


Meike Müller

Contact Press / Media

Dr. Meike Müller

Head of Department of Biomarker Analytics and Development

Phone +49 511 5350-8144