# US 8,465,929 B2 · Biomarkers for ovarian cancer

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- Number: US 8,465,929 B2
- Document ID: US8465929B2
- Status: Granted
- Kind: B2
- Application number: 11/922,652
- Filed: 2006-06-23
- Published: 2010-04-29
- Granted: 2013-06-18
- Earliest claimed: 2005-06-24
- Assignees: Vermillion, Inc.; University of Kentucky Research Foundation
- Applicants: Eric T. Fung; Frederick R. Ueland; J. R. van Nagell; Paul D. Depriest; Andre T. Baron
- Inventors: Eric T. Fung; Frederick R. Ueland; J. R. van Nagell; Paul D. Depriest; Andre T. Baron
- Web page: https://patentgrep.com/patent/US8465929B2

## CPC

- G01N 33/57545: of the ovaries
- A61P 35/00: Antineoplastic agents
- G01N 33/543: with an insoluble carrier for immobilising immunochemicals
- G01N 33/5758: {involving compounds serving as markers for tumours, cancers or neoplasias, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides or metabolites}
- G01N 33/6893: {related to diseases not provided for elsewhere}
- G01N 2333/4725: Mucins, e.g. human intestinal mucin
- G01N 2333/4727: Calcium binding proteins, e.g. calmodulin
- G01N 2333/775: Apolipopeptides
- G01N 2333/79: Transferrins, e.g. lactoferrins, ovotransferrins
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention provides protein-based biomarkers and biomarker combinations that are useful in qualifying ovarian cancer status in a patient. In particular, the biomarkers of this invention are useful to classify a subject sample as ovarian cancer, ovarian cancer of low malignant potential, benign ovarian disease or other malignant condition. The biomarkers can be detected by SELDI mass spectrometry.

## Claims

### Claim 1

A method for qualifying ovarian cancer status in a subject comprising:
(a) measuring Calcyclin, Calgranulin C and Hepcidin in an ovarian cyst fluid, urine, or serum sample from the subject by mass spectrometry or immunoassay to determine the presence, absence, or level of the measured Calcyclin, Calgranulin C and Hepcidin biomarkers, and
(b) correlating the measurements of the presence, absence, or level of the measured Calcyclin, Calgranulin C and Hepcidin biomarkers with ovarian cancer status.

### Claim 2 (depends on 1)

The method of claim 1, further comprising measuring and correlating at least one biomarker selected from the group consisting of: ApoC1, ApoAII, ApoCII, Calgranulin A, and Transthyretin.

### Claim 3 (depends on 1)

The method of claim 1 further comprising measuring CA125.

### Claim 4 (depends on 1)

The method of claim 1, wherein the Calcyclin, Calgranulin C, and Hepcidin are measured by capture on an adsorbent surface of a SELDI probe and detection by laser desorption-ionization mass spectrometry.

### Claim 5 (depends on 4)

The method of claim 4, wherein the adsorbent is a member selected from the group consisting of a hydrophobic adsorbent, an anion exchange adsorbent, a cation exchange adsorbent and a metal chelate adsorbent.

### Claim 6 (depends on 4)

The method of claim 4, wherein the adsorbent is a cation exchange adsorbent.

### Claim 7 (depends on 1)

The method of claim 1, wherein Calcyclin and Hepcidin are measured by immunoassay.

### Claim 8 (depends on 1)

The method of claim 1, wherein the sample is ovarian cyst fluid.

### Claim 9 (depends on 1)

The method of claim 1, wherein the correlating is performed by a software classification algorithm.

### Claim 10 (depends on 1)

The method of claim 1, wherein ovarian cancer status is selected from benign ovarian disease, ovarian cancer of low malignant potential, ovarian cancer and other malignant conditions.

### Claim 11 (depends on 1)

The method of claim 1, wherein the presence of calcyclin rules out benign ovarian disease.

### Claim 12 (depends on 1)

The method of claim 1, wherein the presence of calgranulin C rules out benign ovarian disease.

### Claim 13 (depends on 1)

The method of claim 1, wherein the ovarian cancer status rules out the possibility of benign ovarian disease.

### Claim 14 (depends on 1)

The method of claim 1, wherein the ovarian cancer status rules out the possibility of ovarian cancer and other malignant conditions.

### Claim 15 (depends on 1)

The method of claim 1, further comprising: (c) managing subject treatment based on the status.

### Claim 16 (depends on 15)

The method of claim 15, wherein, if the measurement correlates with ovarian cancer, then managing subject treatment comprises administering a chemotherapeutic agent to the subject.

### Claim 17 (depends on 15)

The method of claim 15, further comprising: (d) measuring Calcyclin, Calgranulin C, and Hepcidin after subject management and correlating the measurement with disease progression.

### Claim 18 (depends on 1)

The method of claim 1, further comprising: (c) reporting the status to the subject.

### Claim 19 (depends on 1)

The method of claim 1, further comprising: (c) recording the status on a tangible medium.