Diagnostic methods for oral cancer
AssigneeNeoDiagnostix, Inc.
InventorsGREGORY ANTON ENDRESS, MADHVI UPENDER, ELIZABETH LIGHT, COLYN CARGILE CAIN
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Abstract
The invention provides for a diagnostic test to monitor cancer-specific genetic abnormalities to diagnose oral cell disorders and predict which patients might progress to cancer. Genetic abnormalities are detected by identification in chromosomal copy number of chromosome 3, chromosome 5 and chromosome 6 using FISH analysis of probes targeted to 3q and/or 5p and/or 11q.
Claims35
1) A method for detecting chromosomal abnormalities to determine presence of oral cancer in a sample comprising:
- hybridizing a patient sample with a nucleic acid probe which binds to a target nucleic acid sequence on chromosome 5p;
- hybridizing a patient sample with a nucleic acid probe which binds to a target nucleic acid sequence on chromosome 11q;
- hybridizing the patient sample with a nucleic acid control probe which binds to centromere of chromosome 6 (CEN6);
- and
- detecting the formation of the hybridization complexes on chromosome 5p, 11q and on CEN6, wherein said detection of hybridized complex indicates an increase in chromosomal copy number as compared to a normal cell and correlates to the presence of oral cell disorder.
2) A method for detecting chromosomal abnormalities to determine presence of oral cancer in a sample comprising:
- hybridizing a patient sample with a nucleic acid probe which binds to a target nucleic acid sequence on chromosome 3q;
- hybridizing a patient sample with a nucleic acid probe which binds to a target nucleic acid sequence on chromosome 11q;
- hybridizing the patient sample with a nucleic acid control probe which binds to a sequence at centromere of CEN6;
- and
- detecting the formation of the hybridization complexes on chromosome 3q, 11q and on CEN6, wherein said detection of hybridization complex indicates an increase in chromosomal copy number as compared to a normal cell and correlates to the presence of oral cell disorder.
3) A method for detecting chromosomal abnormalities to determine presence of oral cancer in a sample comprising:
- hybridizing a patient sample with a nucleic acid probe which binds to a target nucleic acid sequence on chromosome 3q;
- hybridizing a patient sample with a nucleic acid probe which binds to a target nucleic acid on chromosome 5p;
- hybridizing a patient sample with a nucleic acid probe which binds to a target nucleic acid on chromosome 11q;
- hybridizing the patient sample with a nucleic acid control probe which binds to centromere of CEN6;
- and
- detecting the formation of the hybridization complexes on chromosome 5p, on chromosome 3q, on chromosome 11q and on CEN6, wherein said detection of hybridization complex indicates an increase in chromosomal copy number as compared to a normal cell and correlates to the presence of oral disease.
34) An automated method for detecting chromosomal abnormalities to determine presence of cervical cell disease in a patient sample comprising:
- contacting said patient sample comprising cervical cells on a slide with at least two distinguishably labeled probes directed to a portion of a chromosomal region of said cervical cells;
- hybridizing a target nucleic acid region on chromosome 5p or chromosome 3q in said cervical cells with a first said labeled nucleic acid probe;
- hybridizing a target nucleic acid region on chromosome 11q in said cervical cells with a first said labeled nucleic acid probe;
- hybridizing a target nucleic acid region on centromere of chromosome 6 (CEN6) with a second said labeled nucleic acid probe;
- and
- automatically scanning said sample with a microscope to detect the formation of the hybridization complexes on chromosome 5p and on CEN7 and to generate an image after sufficient time and conditions to permit hybridization;
- automatically analyzing said image to characterize the chromosomal profile in said cells to generate a diagnosis;
- and
- automatically reporting said diagnosis to a user.
Dependencies are inferred from the claim text.