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Press Release 03.05.2004
mtm laboratories Announces Granting of US Patent covering its CINtec™Technology.

Heidelberg, Germany, May 3, 2004. mtm laboratories AG, a private biotechnology company focusing on the early detection and prevention of cancer, is pleased to announce the granting of the US patent 6,709,832 entitled "Methods of early diagnosis of carcinomas" covering the company's core technology CINtec™.

mtm's CINtec™technology is based on detecting over-expression of p16ink4a, a cyclin-dependent kinase inhibitor and the first objective cellular marker with tremendous potential for clinical application in early detection and diagnosis of HPV-induced cancers, such as cervical cancer.

The method itself and diagnostic products derived from it are already protected by national patents granted in countries such as Japan, Germany, Russia and Australia. The corresponding European patent was granted during 2003, and is being validated by the national patent offices of 17 further European countries.

Ruediger Ridder, mtm's CSO, said: "mtm laboratories has a unique international patent position and freedom-to-operate using p16ink4a in the field of cervical cancer early detection, the largest early detection market in oncology. p16ink4a is the first cellular marker with the potential to specifically indicate the presence of cervical dysplasia and neoplasia. The significance of p16ink4a-based early detection and diagnostic assays will go beyond a pure risk assessment by simply detecting HPV infection. The prevalence of sexually transmitted HPV infections is high, but only a small number of infected women actually develop clinically significant precancerous and cancerous lesions. The US and European patents are central to the commercialization and protection of our products in the most important markets. We expect the granting of further related patents in the near future."

Peter Pack, CEO, commented: "The successful granting of the US patent is a result of our focussed activities to achieve a solid IP position for our technology and products. The rapidly increasing number of independent, peer-reviewed scientific publications and the recent launch of a first series of CINtec™-based diagnostic products through our development and marketing partner DakoCytomation A/S, Denmark, confirm that we have successfully met crucial milestones on our path to establishing p16ink4a over-expression detection as the first objective parameter for the presence of cervical cancer."

mtm laboratories AG, founded in 1999, is a privately held company based in Heidelberg, Germany. The company develops diagnostic products for the early detection and diagnosis of cancer. In collaboration with DakoCytomation (Denmark), IVD products that apply the CINtec™technology with cervical biopsies (CINtec™p16ink4a Histology kit) and smears (CINtec™p16ink4a Cytology kit) were developed and recently launched in Europe and the United States. In 2003, mtm laboratories successfully closed its second financing round with a total volume of € 12 million.

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