# US 2003/0152993 A1 · Method for the early diagnosis of carcinomas

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- Number: US 2003/0152993 A1
- Document ID: US20030152993A1
- Status: Published application
- Kind: A1
- Application number: 10/371,883
- Filed: 2003-02-20
- Published: 2003-08-14
- Earliest claimed: 1998-07-01
- Inventors: Magnus Von Knebel Doeberitz; Dimitry Spitkovsky
- Web page: https://patentgrep.com/patent/US20030152993A1

## CPC

- G01N 33/57585: {involving compounds identifiable in body fluids}
- G01N 33/5752: of the lungs
- G01N 33/5755: of the uterine cervix, uterine corpus or endometrium
- G01N 33/57557: {of other specific parts of the body, e.g. brain}
- 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)

## Abstract

The present invention relates to a method for the early diagnosis of carcinomas and their preliminary stages, which comprises determining the overexpression of a cell cycle regulatory protein in a body sample. The invention also provides a kit usable for this purpose.

## Claims

### Claim 1

A method for early diagnosing carcinomas and their preliminary stages, comprising determining the overexpression of a cell cycle regulatory protein in a body sample, wherein the cell cycle regulatory protein is a cyclin-dependent kinase inhibitor.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the carcinomas are those of the upper respiratory tract.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the carcinomas are anogenital carcinomas.

### Claim 4 (depends on 3)

The method according to claim 3, wherein the anogenital carcinoma is a cervical carcinoma.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the cyclin-dependent kinase inhibitor is a protein p14, p15, p16, p18, p19, p21 or p27.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the body sample is blood, smears, sputum, urine, bone marrow, organ punctates, biopsies, or lymph.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the overexpression is determined by detecting the nucleic acid encoding the cell cycle regulatory protein.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the overexpression is determined by detecting the cell cycle regulatory protein.

### Claim 9

The method according to claim B, comprising reacting an antibody directed against a cell cycle regulatory protein with the body sample.

### Claim 10 (depends on 1)

A kit for carrying out the method according to claim 1, comprising:
(a) a first reagent for detecting the expression of cyclin-dependent kinase inhibitor, which is selected from the group consisting of a nucleic acid hybridrizing to a cyclin-dependent kinase inhibitor and an antibody directed against a cyclin-dependent kinase inhibitor; and
(b) a second reagent for performing a control reaction, which is selected from the group consisting of a nucleic acid encoding a cyclin-dependent kinase inhibitor, a cyclin-dependent kinase inhibitor, a sample of cells expressing a cyclin-dependent kinase inhibitor, and a preparaton of fixed cells in a suspension or on a side being positive for a cyclin-dependent kinase inhibitor.

### Claim 11 (depends on 10)

The kit according to claim 10, further comprising auxiliary reagents selected form the group consisting of secondary antibodies, reagents for performing a reporter reaction, buffers and stains.