Ventana Medical Systems, Inc.

Mtm Laboratories, Ag

Other

Universitat Heidelberg

Magnus Von Knebel Doeberitz

Peter Martin

Ruediger Ridder

Anja Reichert

Matthias Herkert

Miriam Reuschenbach

Wolfgang Rudy

Rüdiger Ridder

Marcus Trunk-Gehmacher

Rainer Hipfel

Alexander Duwe

Dimitry Spitkovsky

Rudiger Ridder

Madeleine Sauer

Svetlana Vinokurova

The present invention relates to a method for discrimination of p16overexpressing metaplasias from neoplastic or preneoplastic p16overexpressing lesions by determination of the level of high risk HPV encoded gene-products such as e.g. HPV E2 and/or HPV E7 molecules in biological samples in the course of cytological testing procedures. The method thus enables for reduction of false positive results in the p16based detection of anogenital lesions in cytological testing procedures.

Method for discrimination of metaplasias from neoplastic or preneoplastic lesions

The present invention relates to a method for discrimination of p16.sup.INK4a overexpressing metaplasias from neoplastic or preneoplastic p16.sup.INK4a overexpressing lesions by determination of the level of high risk HPV encoded gene-products such as e.g. HPV E2 and/or HPV E7 molecules in biological samples in the course of cytological testing procedures. The method thus enables for reduction of false positive results in the p16.sup.INK4a based detection of anogenital lesions in cytological testing procedures.

This invention provides methods and kits 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 detecting cervical dysplasia

The present invention relates to a method for the early diagnosis of neoplastic disorders such as cancers as well as their precursor stages, particularly cancers of the respiratory tract, the urinary system, the reproductive tract, cancer associated with HPV infection or cancer of the anogenital tract, from solubilized body samples. The invention is also directed to test kits usable for this purpose as well as in-vitro diagnostic devices. The development of the kits and in-vitro diagnostic devices for the above purpose is also one aspect of the present invention.

Method for detecting neoplastic disorders in a solubilized body sample

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 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.

Method for detecting carcinomas in a solubilized cervical body sample

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 body sample. The invention also provides a kit usable for this purpose.

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Heidelberg, Germany

Magnus Von Knebel Doeberitz