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Methods for the cytological analysis of cervical cells

A cervical cell and cervical technology, applied in biochemical equipment and methods, microbiological determination/testing, drug combination, etc., can solve problems such as sampling and interpretation errors, phenotypic changes, and low sensitivity

Inactive Publication Date: 2011-09-28
NEODIAGNOSTIX INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the low sensitivity of cytology alone, frequent follow-up testing is required
This may be because of sampling and interpretation errors, or because some early lesions have not yet had recognizable phenotypic changes

Method used

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  • Methods for the cytological analysis of cervical cells
  • Methods for the cytological analysis of cervical cells
  • Methods for the cytological analysis of cervical cells

Examples

Experimental program
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Effect test

Embodiment 1

[0096] In pre-prepared thin-layer, liquid-based cytology samples (Cytyc, Marlborough, MA) ) for FISH. Depend on Slides are prepared in vials, followed by pretreatments, including protease digestion, formaldehyde fixation, washing and dehydration. Hybridization was performed using a two-color multi-target interphase FISH probe kit (Abbott Molecular Technologies). The kit includes directly labeled probes for the CEN7-light cyan, 3q26 locus (3q-orange) and 5p15 locus (5p-green). Cells were examined with a fluorescence microscope.

[0097] Samples contain at least 800 cells for analysis. Positive test showing aneuploidy and (1) 3q copy number gain or 5p copy number gain measured in 1.0% or more of cells tested; (2) 3q copy number gain only measured in 0.9% or more of cells tested or (3) only a 5p copy number gain was detected in 0.7% or more of the cells tested. A negative test indicates normal ploidy and (1) both 3q and 5p copy number gains in less than 1.0% of cells test...

Embodiment 2

[0100] Figure 6 Comments: This sample showed copy number abnormalities of the TERC gene on 3q26 and the Cri du Chat locus on 5p15. Among the 1000 tested cells, 986 cells were normal, 8 cells were detected with abnormally increased copy number of TERC (3q), 2 cells were detected with abnormally increased copy number of Cri du Chat (5p), and 4 cells were detected with abnormally increased copy number of TERC and Cri du Chat (3q and 5p) copy numbers were abnormally elevated, and the percentage of diseased cells was 1.40%.

Embodiment 3

[0102] Figure 7 Comments: This sample showed normal copy numbers of the TERC gene on 3q26 and the Cri du Chat locus on 5p15. Among the 1000 tested cells, 998 were normal, 2 had abnormally increased copies of TERC (3q), 0 had abnormally increased copies of Cri du Chat (5p), and 0 had abnormally increased copies of TERC and Cri du Chat (3q and 5p) , the percentage of diseased cells was 0.20%.

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Abstract

The invention provides for a diagnostic test to monitor cancer-specific genetic abnormalities to diagnose cervical cell disorders and predict which patients might progress to cancer. Genetic abnormalities are detected by identification in chromosomal copy number of chromosome 3 and chromosome 5 using FISH analysis of probes targeted to 3q and / or 5p.

Description

field of invention [0001] The present invention relates to methods and kits for analyzing chromosomal abnormalities of cervical cells. Background technique [0002] Cervical cancer is one of the most common cancers with high mortality in women worldwide. Cervical cancer and its precursor lesions are effectively treatable if diagnosed early. The main cervical cancer screening method is the Pap test, which uses morphological analysis to identify suspicious cells. However, the sensitivity, reproducibility, and reliability of cell-only assays are relatively low. About 6% of cervical smears (Pap) are diagnosed as atypical squamous cells of undetermined significance (ASCUS), requiring follow-up examinations, and 5-10% of ASCUS patients have no cancer. Patients are currently advised to follow up with Pap tests, human papillomavirus (HPV) tests, and / or colposcopy. [0003] HPV infection is associated with cervical cancer, and many patients undergo HPV testing after obtaining ASC...

Claims

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Application Information

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IPC IPC(8): C12Q1/68A61P35/00G01N33/50
CPCC12Q2600/112C12Q1/6841C12Q1/6886C12Q1/6883C12Q2600/118A61P35/00C12Q1/6816C12Q2600/156C12N15/1068
Inventor G·A·恩德斯M·乌彭德E·S·莱特C·B·卡安
Owner NEODIAGNOSTIX INC
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