Method for the Cytological Analysis of Cervical Cells
AssigneeNeoDiagnostix, Inc.
InventorsGregory Anton Endress, Madhvi Upender, Elizabeth Light, Colyn Cain
Life of this patent
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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.
Claims31
1-35. (canceled)
A method for detecting chromosomal abnormalities in a plurality of cells in a cervical sample, said method comprising:
- a) hybridizing a first nucleic acid sequence to a target nucleic acid sequence on chromosome 3q;
- b) hybridizing a second nucleic acid sequence to a target nucleic acid sequence on chromosome 5p;
- c) detecting the hybridization signal of the first and second nucleic acid sequences, wherein the hybridization signal is indicative of chromosomal copy number for 3q and 5p
- d) scoring the chromosomal copy number for chromosome 3q and 5p;
- and
- e) reporting whether the sample contains chromosomal abnormalities, wherein a lack of chromosomal abnormalities in the sample exists when a ratio of the chromosomal copy number for chromosome 3q to the total number of nuclei is less than 2 and the chromosomal copy number for chromosome 5p to the total number of nuclei is less than 2.
The method of 36, wherein the target nucleic acid sequence on chromosome 5p is at locus 5p15, 5p15.3 or 5p15.2.
Dependencies are inferred from the claim text.