# US 2015/0147748 A1 · In situ detection of early stages and late stages hpv infection

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- Number: US 2015/0147748 A1
- Document ID: US20150147748A1
- Status: Published application
- Kind: A1
- Application number: 14/335,511
- Filed: 2014-07-18
- Published: 2015-05-28
- Earliest claimed: 2009-06-10
- Assignees: OncoHealth Corp.
- Inventors: Shuling Cheng
- Web page: https://patentgrep.com/patent/US20150147748A1

## CPC

- G01N 33/56983: {Viruses}
- C07K 16/084: Papillomaviridae (F); Polyomaviridae (F), e.g. SV40, BK virus or JC virus
- C12Q 1/708: {for papilloma}
- G01N 33/571: for venereal disease, e.g. syphilis, gonorrhoea {(herpes G01N33/56994; chlamydia G01N33/56927)}
- G01N 2333/025: Papovaviridae, e.g. papillomavirus, polyomavirus, SV40, BK virus, JC virus
- G01N 2469/10: Detection of antigens from microorganism in sample from host
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

Embodiments of the invention provide methods, monoclonal antibodies, polyclonal antibodies, assays, and kits for detecting HPV infection and HPV related cancer diagnosis, including infection by various HPV genotypes, early and/or late stage HPV-associated or HPV-specific cancers. The anti-HPV antibodies are used in performing immunological assays on clinical samples. Various immunological assays and kits for detecting HPV infection, cervical cancer, other HPV related cancers, early stage precancerous lesions as well as late stage cancer progression are also provided.

## Claims

### Claim 1

A method of detecting papillomavirus infection in a human subject, comprising:
providing a clinical sample from the human subject, the clinical sample is processed into a liquid-based solution containing a mixture of morphologically abnormal and normal human cells;
staining the mixture of the morphologically abnormal and normal human cells using one or more antibodies generated against one or more purified recombinant papillomavirus proteins, wherein the one or more antibodies are each tagged with an agent, and at least one antibody is capable of binding to a papillomavirus early viral protein;
conducting one or more flow cytometry assays to detect each individual cells by separating each cell from the mixture of the morphologically abnormal and normal human cells; and
detecting the presence of one or more human papillomavirus viral proteins from one or more papillomavirus types in the mixture of the morphologically abnormal and normal human cells contained in the liquid-based solution from the clinical sample.

### Claim 2 (depends on 1)

The method of claim 1, wherein the one or more antibodies further comprises two or more anti-HPV antibodies each pre-labeled with different agents and used in one binding reaction to detect the presence of two or more human papillomavirus viral proteins.

### Claim 3

A kit for detecting papillomavirus infection in a human subject, comprising:
an anti-HPV monoclonal antibody, capable of binding to a papillomavirus early protein for conducting an immunocytochemistry assay on a clinical sample from the human subject processed into a solution containing a mixture of morphologically abnormal and normal human cells and applied into a thin layer of cells on a slide for staining in situ one or more papillomavirus viral proteins from one or more papillomavirus types present in the clinical sample on the slide containing the mixture of morphologically abnormal and normal human cells.

### Claim 4 (depends on 3)

The kit of claim 3, wherein the anti-HPV antibody is selected from the group consisting of an anti-HPV E7 monoclonal antibody, an anti-HPV E6 monoclonal antibody, a combination of an anti-HPV L1 antibody and anti-HPV E7 monoclonal antibody, a combination of an anti-HPV L1 antibody and anti-HPV E6 monoclonal antibody, a combination of an anti-HPV E6 antibody and anti-HPV E7 monoclonal antibody.

### Claim 5 (depends on 3)

The kit of claim 3, wherein the one or more papillomavirus types are selected from the group consisting of high risk HPV types, low risk HPV types, HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, and HPV-68, HPV-6, HPV-11, HPV-42, HPV-43, HPV-44, HPV-53, HPV-54, HPV-55, and HPV-56, and combinations thereof.