# US 10,371,704 B2 · Method for discriminating between prostate cancer and a benign prostate disease

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,371,704 B2
- Document ID: US10371704B2
- Status: Granted
- Kind: B2
- Application number: 15/108,283
- Filed: 2013-12-27
- Published: 2016-10-27
- Granted: 2019-08-06
- Earliest claimed: 2013-12-27
- Assignees: Konica Minolta, Inc.
- Applicants: Konica Minolta, Inc.
- Inventors: Katsuko Yamashita; Takatoshi Kaya; Youichi Ide; Tomonori Kaneko
- Web page: https://patentgrep.com/patent/US10371704B2

## CPC

- G01N 33/57555: of the prostate
- G01N 33/6893: {related to diseases not provided for elsewhere}
- G01N 2333/42: Lectins, e.g. concanavalin, phytohaemagglutinin
- G01N 2333/4725: Mucins, e.g. human intestinal mucin
- G01N 2800/342: Prostate diseases, e.g. BPH, prostatitis
- 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

A method of analyzing diagnostic information, the method including: measuring a concentration of a mucin-1 (Tn-MUC1), which is reactive with a lectin that recognizes and binds to an N-acetyl-D-galactosamine→serine (threonine) residue, in a blood sample originated from a subject to be diagnosed; comparing the measured value with a threshold value; and estimating that a disease affecting the subject to be diagnosed is not prostate cancer but a benign prostate disease when the measured value of the concentration of Tn-MUC1 is greater than the threshold value.

## Claims

### Claim 1

A method for detecting a reactive mucin-1 in a subject, said method comprising:
(a) measuring the concentration of said reactive mucin-1, said reactive mucin-1 being reactive with a lectin that recognizes and binds to an N-acetyl-D-galactosamine→serine (threonine) residue, in a blood sample originated from said subject, to provide a measured reactive mucin-1 concentration value;
(b) determining a reactive mucin-1 threshold value for said reactive mucin-1 comprising:
(b)(1) measuring the concentration of said reactive mucin-1 in blood samples from a plurality of patients who have been diagnosed with prostate cancer,
(b)(2) measuring the concentration of said reactive mucin-1 in blood samples from a plurality of patients who have been diagnosed with a benign prostate disease, and
(b)(3) selecting, as said reactive mucin-1 threshold value, the lowest concentration value measured from step (b)(2) which is higher than the highest concentration value measured from step (b)(1);
(c) determining whether said measured reactive mucin-1 concentration value is greater than said reactive mucin-1 threshold value.

### Claim 2

A method for detecting a reactive mucin-1 and a total mucin-1 in a subject, said method comprising:
(i)(a) measuring the concentration of said reactive mucin-1, said reactive mucin-1 being reactive with a lectin that recognizes and binds to an N-acetyl-D-galactosamine→serine (threonine) residue, in a blood sample originated from said subject, to provide a measured reactive mucin-1 concentration value;
(i)(b) determining a reactive mucin-1 threshold value comprising:
(i)(b)(1) measuring the concentration of said reactive mucin-1 in blood samples from a plurality of patients who have been diagnosed with prostate cancer,
(i)(b)(2) measuring the concentration of said reactive mucin-1 in blood samples from plurality of patients who have been diagnosed with a benign prostate disease, and
(i)(b)(3) selecting, as said reactive mucin-1 threshold value, the lowest concentration value measured from step (i)(b)(2) which is higher than the highest concentration value measured from step (i)(b)(1);
(ii)(a) measuring the concentration of said total mucin-1 in said blood sample originated from said subject to provide a measured total mucin-1 concentration value;
(ii)(b) determining a total mucin-1 threshold value comprising:
(ii)(b)(1) measuring the concentration of said total mucin-1 in blood samples from said plurality of patients who have been diagnosed with prostate cancer,
(ii)(b)(2) measuring the concentration of said total mucin-1 in blood samples from said plurality of patients who have been diagnosed with a benign prostate disease, and
(ii)(b)(3) selecting, as said total mucin-1 threshold value, the lowest concentration value measured from step (ii)(b)(2) which is higher than the highest concentration value measured from step (ii)(b)(1);
(iii)(a) determining whether said measured reactive mucin-1 concentration value is greater than said reactive mucin-1 threshold value; and
(iii)(b) determining whether said measured total mucin-1 concentration value is greater than said total mucin-1 threshold value.

### Claim 3

A method detecting a reactive mucin-1 and a total prostate-specific antigen in a subject, said method comprising:
(i)(a) measuring the concentration of said reactive mucin-1, said reactive mucin-1 being reactive with a lectin that recognizes and binds to an N-acetyl-D-galactosamine→serine (threonine) residue, in a blood sample originated from said subject, to provide a measured reactive mucin-1 concentration value;
(i)(b) determining a reactive mucin-1 threshold value comprising:
(i)(b)(1) measuring the concentration of said reactive mucin-1 in blood samples from a plurality of patients who have been diagnosed with prostate cancer,
(i)(b)(2) measuring the concentration of said reactive mucin-1 in blood samples from plurality of patients who have been diagnosed with a benign prostate disease, and
(i)(b)(3) selecting, as said reactive mucin-1 threshold value, the lowest concentration value measured from step (i)(b)(2) which is higher than the highest concentration value measured from step (i)(b)(1);
(ii)(a) measuring the concentration of said total prostate-specific antigen in a blood sample originated from said subject to provide a measured total prostate-specific antigen concentration value;
(ii)(b) determining a total prostate-specific antigen threshold value comprising:
(ii)(b)(1) measuring the concentration of total prostate-specific antigen in blood samples from said plurality of patients who have been diagnosed with prostate cancer,
(ii)(b)(2) measuring the concentration of total prostate-specific antigen in blood samples from said plurality of patients who have been diagnosed with a benign prostate disease, and
(ii)(b)(3) selecting, as said total prostate-specific antigen threshold value, the lowest concentration value measured from step (ii)(b)(1) which is higher than the highest concentration value measured from step (ii)(b)(2);
(iii) determining whether said measured reactive mucin-1 concentration value is greater than said reactive mucin-1 threshold value; and
(iv) determining whether said measured total prostate-specific antigen concentration value is greater than said total prostate-specific antigen threshold value.

### Claim 4 (depends on 1)

The method according to claim 1, wherein said lectin that recognizes and binds to said N-acetyl-D-galactosamine→serine (threonine) residue is Wisteria floribunda lectin.

### Claim 5 (depends on 1)

The method according to claim 1, wherein said benign prostate disease is prostatic hyperplasia.

### Claim 6 (depends on 1)

The method according to claim 1, wherein said reactive mucin-1 or total mucin-1 is reactive with an anti-KL-6 monoclonal antibody.

### Claim 7 (depends on 1)

The method according to claim 1, wherein said subject is a human.

### Claim 8 (depends on 1)

The method according to claim 1, wherein said benign prostate disease is benign prostatitis.

### Claim 9 (depends on 1)

The method according to claim 1, wherein said reactive mucin-1 is reactive with an anti-mucin-1 antibody.

### Claim 10 (depends on 2)

The method according to claim 2, wherein said reactive mucin-1 is reactive with an anti-mucin-1 antibody and said total mucin-1 is reactive with said anti-mucin-1 antibody.

### Claim 11 (depends on 3)

The method according to claim 3, wherein said reactive mucin-1 is reactive with an anti-mucin-1 antibody.