# US 2014/0154711 A1 · Detection of defensins to diagnose cancer

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- Number: US 2014/0154711 A1
- Document ID: US20140154711A1
- Status: Published application
- Kind: A1
- Application number: 14/095,472
- Filed: 2013-12-03
- Published: 2014-06-05
- Earliest claimed: 2012-12-03
- Assignees: Board of Trustees of the University of Arkansas; Ascendant Diagnostics, LLC
- Applicants: Ascendant Diagnostics
- Inventors: Anna Daily; Rohana Liyanage; Jackson O. Lay
- Web page: https://patentgrep.com/patent/US20140154711A1

## CPC

- G01N 33/57515: of the breast
- G01N 2333/4721: Cationic antimicrobial peptides, e.g. defensins
- 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

Non-invasive methods of detecting and providing an early diagnosis of cancer, in particular breast cancer are provided herein. The methods include obtaining a sample, suitably an ocular wash sample, from a subject and determining the level of α-Defensin 1, α-Defensin 2 and/or α-Defensin 3 in the sample. Increased levels of any of these proteins as compared to a negative control or non-cancerous subject are indicative of cancer in the subject from which the sample was obtained. Kits for performing the methods described herein are also provided.

## Claims

### Claim 1

A method of determining whether a subject is likely to have cancer comprising: obtaining a sample from the subject; performing steps for or detecting the level of at least one of α-Defensin 1, α-Defensin 2 or α-Defensin 3 in the sample; and determining the subject has cancer if the levels of α-Defensin 1, α-Defensin 2 or α-Defensin 3 are increased as compared to the levels in a control sample.

### Claim 2 (depends on 1)

The method of claim 1, wherein the cancer is breast cancer, the subject is a human and the sample is an ocular wash sample.

### Claim 3 (depends on 1)

The method of claim 1, wherein all three Defensins are increased in the sample as compared to a negative control.

### Claim 4

A method of determining whether a subject is likely to have cancer comprising: obtaining a sample from the subject; preparing the sample for liquid chromatography-mass spectroscopy; collecting liquid chromatography-mass spectroscopy spectra of the sample; identifying whether the sample contains peaks with increased intensity corresponding to at least one of α-Defensin 1, α-Defensin 2 or α-Defensin 3 in the sample; and determining the subject is at increased risk of having cancer if the subject has a peak with increased intensity corresponding to any one of α-Defensin 1, α-Defensin 2 or α-Defensin 3 as compared to the levels in a control sample.

### Claim 5 (depends on 4)

The method of claim 4, wherein the peaks with increased intensity are found at about 3375 Daltons, about 3445 Daltons or about 3488 Daltons.

### Claim 6 (depends on 4)

The method of claim 4, wherein the sample is an ocular wash.

### Claim 7 (depends on 4)

The method of claim 4, wherein the subject is human.

### Claim 8 (depends on 4)

The method of claim 4, wherein the subject is suspected of having cancer.

### Claim 9 (depends on 4)

The method of claim 4, wherein the subject is at increased risk for developing a cancer.

### Claim 10 (depends on 4)

The method of claim 4, wherein the cancer is breast cancer.

### Claim 11 (depends on 10)

The method of claim 10, wherein the subject has a palpable lump suspected of being cancerous.

### Claim 12 (depends on 4)

The method of claim 4, wherein the cancer is detected as a stage II breast cancer.

### Claim 13 (depends on 4)

The method of claim 4, wherein all three Defensins are increased in the sample from subjects likely to have cancer.

### Claim 14 (depends on 4)

The method of claim 4, wherein the subject is likely to have cancer when the level of at least one of α-Defensin 1, α-Defensin 2 or α-Defensin 3 is increased 5 fold as compared to levels in a negative control sample.

### Claim 15

A kit for detecting cancer in a subject, the kit comprising an antibody capable of detecting at least one of α-Defensin 1, α-Defensin 2 or α-Defensin 3 and instructions for performing the assay.

### Claim 16 (depends on 15)

The kit of claim 15, further comprising reagents for performing an enzyme linked immunosorbent assay.

### Claim 17 (depends on 15)

The kit of claim 15, further comprising controls for analyzing the results of the assay.

### Claim 18

A method of determining whether a subject is likely to have cancer comprising: obtaining a sample from the subject; performing an antibody based detection assay on the sample to detect the presence and/or level of at least one of α-Defensin 1, α-Defensin 2 or α-Defensin 3 in the sample; and determining the subject is likely to have cancer if the levels of α-Defensin 1, α-Defensin 2 or α-Defensin 3 are increased as compared to the levels in a control sample.

### Claim 19 (depends on 18)

The method of claim 18, wherein the antibody based detection assay is an enzyme linked immunosorbent assay using an antibody specific for at least one of α-Defensin 1, α-Defensin 2 or α-Defensin 3.

### Claim 20 (depends on 19)

The method of claim 19, wherein the enzyme linked immunosorbent assay is performed as a rapid assay using a test strip.

### Claim 21 (depends on 19)

The method of claim 19, wherein the enzyme linked immunosorbent assay provides a colorimetric concentration dependent read-out.
