Before medications are approved they must run through many tests – first in cell cultures and animal models, and finally under strict conditions in clinical studies with humans. Various biological parameters known as biomarkers make it possible to measure if biological processes are running normally or abnormally inside the body. The effects of medication and the treatment process can be monitored in this way. Biomarkers differ between humans and animals however, so for the development of medication there has to be a great number of different tests for analysis.

High-Tech Gründerfonds finances test development

The research team under Oliver Pötz from the Natural and Medical Sciences Institute (NMI) at the University of Tübingen is working on reliable biomarker tests for drug development, which cannot be applied for humans only, but also cross-species for animals. As a winner of the GO-Bio competition 2012, the team founded the company Signatope GmbH. Now the start-up company has received 600,000 Euros from the High-Tech Gründerfonds (HTGF) to develop the protein test. “The team was able to convince us with their promising technology. Non-invasive biomarker test procedures in opposition to tissue section procedures are gaining importance in drug development.”, says Lena Krzyzak, Investment Manager at HTGF.

Providing evidence of organ damage and drug reactions

“Our procedure delivers quantifiable comparable data, independent of the test model. We can identify biomarkers even in the smallest urine or blood samples. This spares significant time and costs for drug development.”, Oliver Pötz, CEO at Signatope, explains. With our highly specific protein tests, it’s possible to gather evidence of organ damage or drug reactions. These assays are suitable for preclinical studies as well as clinical Phase I studies in drug development because of their cross-species application. This allows pharmaceutical companies to develop medication more specifically and efficiently.

Increased safety in drug development

Due to the assays, the development of medication becomes safer, according to the company. This is important because there are still cases where medications have to be taken off the market owing to their toxic characteristics, even though they had intensive preclinical investigations and approval. Here the Signatope procedure can help. With its method the toxicity of substances can already be predicted in early development phases. Also, the method could help to decrease the number of animal tests required. The start-up company has since been able to win over renowned customers for their analytics service from the pharmaceutical sector.

bp