ASSESSMENT OF HUMAN PAPILLOMA VIRUS-RELATED DISEASE

• US 20070154884A1
• Filed: 03/02/2007
• Published: 07/05/2007
• Est. Priority Date: 12/12/1997
• Status: Active Grant

• Current Assignee: QIAGEN Gaithersburg, Inc. (Qiagen NV)
• Original Assignee: QIAGEN Gaithersburg, Inc. (Qiagen NV)
• Inventors: Lorincz, Attila, Lazar, James
• Granted Patent: US 7,879,546 B2
• Time in Patent Office: Days
• US Class Current: 435/5
• CPC Class Codes: A01N 1/021 Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
• CPC Class Codes: C12Q 1/6806 Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay C12Q1/6804 takes precedence
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: C12Q 1/708 for papilloma
• CPC Class Codes: C12Q 2523/101 Crosslinking agents, e.g. psoralen
• CPC Class Codes: C12Q 2543/10 the purpose being "in situ" analysis
• CPC Class Codes: C12Q 2545/114 involving a quantitation step
• CPC Class Codes: C12Q 2600/112 Disease subtyping, staging or classification
• CPC Class Codes: C12Q 2600/118 Prognosis of disease development

Abstract

This invention provides novel methods for assessing HPV infection. Gene expression levels are used to assess the progression of HPV infection from benign to malignant growth. Also provided are kits for carrying out the methods of this invention.

Claims

1. A method of detecting HPV-induced cell transformation in a patient infected with HPV comprising the steps of:

measuring HPV-expressed mRNA levels from a sample collected from said patient, said mRNAs comprising one or more of E6 mRNA, E7 mRNA, E2 mRNA E1 mRNA, E4 mRNA, L2 mRNA and L1 mRNA;

determining expression level of E6 and/or E7 and expression level of E2 and/or L1 such that a ratio of E6 and/or E7 to L1 and/or E2 is determined, wherein a ratio of greater than 2 is indicative of HPV-induced cell transformation and risk of neoplasia.

2. A method of predicting the onset of HPV-induced cancer in a patient infected with HPV comprising the steps of:

measuring a group I and a group II and/or a group III HPV mRNA from a sample collected from said patient;

determining ratio of group I mRNA level to group II and/or group III mRNA level wherein a ratio of greater than 2 is indicative of neoplastic onset.

3. A method of monitoring stage of HPV-induced disease in a patient infected with HPV comprising the steps of:

measuring HPV-expressed mRNA levels from a sample collected from said patient;

determining expression level of E6 and/or E7 and expression level of E2 and/or L1; and

determining a ratio of E6 and/or E7 expression level to L1 and/or E2 expression level wherein a ratio of greater than 2 is indicative or neoplastic change.

4. A method of detecting HPV-induced cancer in a patient infected with HPV comprising the steps of:

measuring HPV-expressed mRNA levels from a sample collected from said patient, said mRNAs comprising one or more of E6 mRNA, E7 mRNA, E2 mRNA and L1 mRNA;

determining expression level of E6 and/or E7 and expression level of E2 and/or L1 such that a ratio of E6 and/or E7 to L1 and/or E2 is determined, wherein a ratio of greater than 4 is indicative of HPV-induced cancer.

5. A method of predicting the risk or onset of HPV-induced cancer in a patient infected with HPV comprising the steps of:

measuring a group I and a group II and/or a group III HPV mRNA from a sample collected from said patient;

determining ratio of group I mRNA level to group II and/or group III mRNA level wherein a ratio of greater than 4 is indicative of HPV-induced cancer onset.

6. A kit comprising at least two probes capable of detecting HPV RNA, wherein at least one probe is selected from the group consisting of E2, E4, E6 and E7, and at least one probe is selected from the group consisting of L1, L2, E1, E2, E4, and E5.

7. The kit according to claim 6, wherein at least one probe is a DNA probe.