HAMBURG, Germany — With the founding of Adnagen GmbH, a DNA diagnostics company based in Hanover, the first company devoted solely to medical DNA diagnosis has been launched in Germany.

The start-up is a spin-off of the Fraunhofer Gesellschaft's Institute for Interfacial Engineering and Biotechnology, in Stuttgart, Germany. With a primary focus on occupational health and environmental medicine, Adnagen expects to become a leading company in medical DNA diagnostics in the coming years.

The Fraunhofer Gesellschaft, the leading organization of applied research in Germany, operates 47 research institutes with about 9,000 employees, half of them scientists and engineers, and is expanding to become a worldwide organization, with institutes in the U.S. and Asia.

Two years ago, the Fraunhofer Gesellschaft's Institute for Interfacial Engineering and Biotechnology started a DM2.5 million in-house project to improve the efficiency of DNA diagnostics.

Company Already Holding Partnership Talks

One of the researchers, Gero Waschütza, developed a proprietary assay for a quick and reliable diagnosis of genes relevant for the metabolism of drugs and xenobiotics. This method now serves as a platform technology for the new company, whose name, Adnagen, is derived from "advanced DNA genetics." The start-up was founded with the University of Hanover's Institute for Microbiology.

"DNA diagnostics is a vast market," Waschütza, scientific founder of Adnagen, told BioWorld International. "Such methods will replace conventional biochemical diagnosis as they are faster, cheaper and more accurate. We hope to achieve sales of DM1 million to DM2 million per year soon."

He added Adnagen already is discussing marketing contracts with several European companies and is negotiating with a major venture capital fund. Adnagen starts with its proprietary Hepargnost assay, which analyzes the genotype of liver enzymes.

"Today, we know of several genetic polymorphisms in genes coding for enzymes involved in the breakdown of drugs, pollutants and poisons which enter the body by food, air or through skin," Waschütza explained.

Depending on the activity of the different types of enzymes, the speed of the steps during detoxification varies. This leads to different levels of harmful intermediates or to bioaccumulation of xenobiotics. Some of these polymorphisms seem to be responsible for a higher susceptibility to cancers of the colon, bladder or mammae.

"In occupational or environmental diseases such as allergies, asthma or neurodermitis, we can test for the different genotypes and provide a detailed analysis of the individual risk," Waschütza said. "Then therapeutic or dietary recommendations can be made."

Adnagen plans to extend its services to other diseases such as osteoporosis and will develop high-throughput and automated systems. Several patents on assays have been filed so far.

"In addition, we offer genotyping for clinical studies," Waschütza said. "Pharmaceutical companies have recognized the need for thorough genotyping of probands testing new drugs to be able to analyze the metabolic response in the participants in detail."

Last year, Waschütza received the "Young Investigator Award" from the International Society for Interferon and Cytokine Research for his construction of a modified Interferon-gamma by molecular modeling. The new Interferon-gamma-HS is more heat-resistant and stable as the natural molecule.