Method for specific detection of tumor cell and its precursor in cervix smear by simultaneously measuring at least two different molecular labels

Abstract

The present invention relates to an automatable method for obtaining an improved diagnosis of cancer, and its precancerous stages in uterine cervical smears by simultaneously staining and detecting at least two different molecular markers, which exhibit a disease-associated change in gene expression, in a cell by means of using antibodies or nucleic acid probes.

Description

Background technique [0001] Cancerous diseases remain one of the most common causes of death worldwide. Early identification and specific detection methods of cancer and precancer are clinically needed in order to prevent tumor progression through early therapeutic intervention. Thus, preventive programs have been offered for a number of cancers (especially cervix, breast and bowel) since the 1950's, and the use of these programs in many countries has resulted in a reduction in mortality. [0002] In the case of cervical cancer in women, the medical examination is mainly based on the morphological / cytological examination of a smear of cells taken from the cervix, ie it is called the PAP test. However, this test has only limited sensitivity (up to 40% false negative diagnoses, Duggan et al; 1998, EurJ Gynaecol Oncol; 19:209-214; Bishop et al, 1996, Buss Pan AmHealth Organ, 30, 378-86) . Furthermore, up to 10% of smears were classified as ASCUS (atypical squamous cells of und...

AI Technical Summary

Problems solved by technology

This method has several disadvantages: the fact that it consumes a large amount of patient sample material and staining reagents, while sample material is usually limited, staining reagents are time-consuming and expensive, and the fact that it is impossible to clearly detect two or more markers

[0012] Patent US-6005256 (whose authors are McGlynn and Akkapeddi) describes in detail a device and method for simultaneously detecting multiple fluorescently-labeled markers in a body sample, as well as a device and method for identifying cancer cells, but it has not been implemented to cancer diagnosis specific application or indicate that appropriate marker combinations can yield higher specificity