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A spin-off from the University of Freiburg and the Medical Center – University of Freiburg is developing tests designed to make new gene therapies safer

BiObservR, a future spin-off from the University of Freiburg and the Medical Center – University of Freiburg, will receive approximately 1.2 million euros in funding starting in April 2026 as part of the EXIST startup grant from the Federal Ministry for Economic Affairs and Energy (BMWE). The company is developing specialized testing methods for new gene therapies. These methods are designed to detect early on whether a treatment not only acts at the intended site in the genome but may also trigger unintended changes. This will allow risks to be better identified before new therapies are used in clinical trials with patients.

“We examine very closely what happens in the treated cells after genome editing,” says Dr. Sandra Ammann, future co-founder of BiObservR and a biologist at the Institute of Transfusional Medicine and Genetherapy at the Medical Center – University of Freiburg. “To do this, we combine modern laboratory techniques with bioinformatics analyses. Ultimately, developers gain the clearest possible picture of whether their therapy is safe enough to proceed to the next stage of development.”

Detecting Unintended Changes in the Genome

With modern gene therapies such as CRISPR, specific sections of the genome can be targeted for modification. This opens up new treatment options, for example for severe congenital disorders. At the same time, it must be carefully verified whether other sites in the genome are also altered in the process. Such unintended changes are called off-target effects and can pose a safety risk. “Among other things, we have developed a method that can precisely detect chromosomal rearrangements. This allows us to address a key challenge in the safety assessment of gene-editing therapies,” says Ammann. To do this, the team examines treated cells in the laboratory and analyzes the results using computer-aided methods. 

The spin-off thus supports research institutions and companies developing new gene and cell therapies by conducting critical safety assessments prior to clinical trials and during the regulatory approval process.

BiObservR builds on many years of research at the University of Freiburg and the Medical Center – University of Freiburg. The EXIST program of the Federal Ministry for Economic Affairs and Energy supports technology-oriented spin-offs from universities and research institutions in transferring scientific innovations into practical applications.