Mtm Laboratories, Ag

Ventana Medical Systems, Inc.

Rüdiger Ridder

Peter Martin

Magnus Von Knebel Doeberitz

Anja Reichert

Matthias Herkert

Marcus Trunk-Gehmacher

Wolfgang Rudy

Michael Mengel

Reinhard Von Wasielewski

The present invention concerns a method for predicting the potential for aggressive growth and/or the risk to progress to high grade cancer for tumors in cell based detection procedures. In one aspect the invention concerns the detection of overexpression of cyclin-dependent kinase inhibitor gene products as a tool for predicting the progression risk and/or potential for aggressive growth of tumors. In a second aspect the invention concerns predicting the progression risk and/or potential for aggressive growth in tumors on the basis of the simultaneous co-detection of the presence of overexpression of cyclin-dependent kinase inhibitor gene products together with the expression of markers for active cell proliferation. Further the invention concerns preparations of probes for diagnosis namely for predicting the progression risk and/or the potential for aggressive growth of tumors.

Method for prediction of the progression risk of tumors

This invention provides methods for improved diagnosis of medically relevant conditions by solution based biochemical testing procedures performed in solutions of test samples. The invention provides a method to substitute the cell based morphological information contained within the cytological and/or histological data of the test sample by molecular information obtainable from the solution, wherein the original test sample is dissolved and thus enables for accurate and reproducible assessment of medically relevant diagnosis from dissolved test samples. The method according to the invention comprises the steps of determining the levels of one or more disease markers associated with the condition to be diagnosed, determining the level of one or more normalization markers suitable to substitute the information related to morphological aspects of the sample, comparing and/or combining the data of the disease and normalization markers, and assessing diagnosis of a medically relevant condition.

Method for solution based diagnosis

The present invention provides a method for diagnosis, monitoring and prognosticating the disease course of gastrointestinal tumors, comprising determining the level of a cyclin dependent kinase inhibitor (CK1) in a sample and diagnosing the disease and/or recurrence of the disease or prognosticating the disease course from the level of said CK1 in the examined tumor cells. Furthermore the present invention provides a method for tailoring a suitable therapy for gastrointestinal tumors. Another aspect of the present invention are test kits for research and diagnostic purposes.

Method for monitoring and prognosis of disease course of gastrointestinal tumors

The present invention relates to a method for the early diagnosis of carcinomas and their preliminary stages, which comprises determining the overexpression of a cell cycle regulatory protein in a solubilized body sample. The present invention is particularly directed to a method for detecting cervical carcinomas, cervical intraepithelial neoplasias, or cervical carcinomas in-situ from a solubilized cervical body sample of a human subject, by solubilizing the cervical body sample in a lysis buffer, and determining the overexpression of cyclin dependent kinase inhibitor p16 in the solubilized cervical sample. The invention also concerns a test kit usable for this purpose as well as an in-vitro diagnostic device.

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Schriesheim, Germany

Rüdiger Ridder