# US 2014/0154680 A1 · Diagnostic, predictive and prognostic testing for cancer

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- Number: US 2014/0154680 A1
- Document ID: US20140154680A1
- Status: Published application
- Kind: A1
- Application number: 13/873,487
- Filed: 2013-04-30
- Published: 2014-06-05
- Earliest claimed: 2007-10-15
- Assignees: Cambridge Cancer Diagnostics Limited
- Inventors: Kai STOEBER; Gareth HAYDEN WILLIAMS
- Web page: https://patentgrep.com/patent/US20140154680A1

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- A61P 35/00: Antineoplastic agents
- G01N 33/575: for cancer
- 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 2800/56: Staging of a disease; Further complications associated with the disease
- 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
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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 generally to the field of cancer. In particular, the present invention relates to cancer prognostic and treatment protocols.

## Claims

### Claim 1

A method for determining a treatment protocol for a subject having cancer, the method comprising the in vitro steps of:
a) assessing the level of a first biomarker selected from at least one of Mcm2 to 7 in a biological sample from the subject; and
b) assessing the level of a second biomarker selected from at least one of geminin, Aurora A, Plk1 and H3S10ph in a biological sample from the subject,
wherein the combination of the level of the first biomarker compared to a pre-determined value and the level of the second biomarker compared to a predetermined value is indicative of the treatment regimen prescribed for the subject.

### Claim 2

A method for predicting therapeutic treatment response of a subject having cancer, the method comprising the steps of:
a) assessing a level of a first biomarker selected from at least one of Mcm2 to 7 in a biological sample from the subject; and
b) assessing the level of a second biomarker selected from at least one of geminin, Aurora A, Plk1 and H3S10ph in a biological sample from the subject;
wherein the combination of the level of the first biomarker compared to a pre-determined value and the level of the second biomarker compared to a predetermined value is indicative of the efficacy of the therapeutic treatment.

### Claim 3

A method for determining the progression of a cancer in a subject, comprising the in vitro steps of:
a) assessing the level of a first biomarker selected from at least one of Mcm2 to 7 in a biological sample from the subject; and
b) assessing the level of a second biomarker selected from at least one of geminin, Aurora A, Plk1 and H3S10ph in a biological sample from the subject,
wherein the combination of the level of the first biomarker compared to a pre-determined value and the level of the second biomarker compared to a predetermined value is indicative of cancer progression in the subject.

### Claim 4 (depends on 1)

The method of claim 1, further comprising assessing the level of a third biomarker selected from at least one of geminin, Aurora A, Plk1 and
H3S10ph in the biological sample from said subject, wherein the second and third biomarkers are different.

### Claim 5 (depends on 1)

The method of claim 1, wherein when the level of the first biomarker compared to a pre-determined value is low and the level of the second biomarker compared to a pre-determined value is low, the treatment regimen is selected from one or more of:
a) monitoring; and
b) treatment with non-cell-cycle phase specific chemotherapeutic agents.

### Claim 6 (depends on 1)

The method of claim 1, wherein when the level of the first biomarker compared to a predetermined value is high and the level of the second biomarker compared to a pre-determined value is low, the treatment regimen is selected from one or more of:
a) monitoring; and
b) treatment with G1 or non-cell cycle phase specific chemotherapeutic agents.

### Claim 7 (depends on 1)

The method of claim 1, wherein when the level of the first biomarker compared to a pre-determined value is high and the level of the second biomarker compared to a pre-determined value is high, the treatment regimen is treatment with S, G2 or M cell cycle phase specific chemotherapeutic agents.

### Claim 8 (depends on 1)

The method of claim 1, wherein the biological sample is selected from the group consisting of tumor biopsy tissue, whole blood, blood plasma, blood serum, cervical smears, urine, prostatic massage specimens, bronchio-lavage, sputum and brushings from the alimentary tract.

### Claim 9 (depends on 1)

The method of claim 1, wherein the level of the first and second biomarker is determined using an immunological assay method.

### Claim 10 (depends on 9)

The method of claim 9, wherein the immunological assay method is selected from the group consisting of immunohistochemistry, immunocytochemistry, dot blot analysis, slot blot analysis, RIA, peptide microarray, and ELISA.

### Claim 11 (depends on 1)

The method of claim 1, wherein the level of the first and second biomarker is determined using a molecular biological-based assay methods.

### Claim 12 (depends on 11)

The method of claim 11, wherein the molecular biological-based assay method is selected from the group consisting of Northern blot analysis, Southern blot analysis, Western blot analysis, RT-PCR, PCR, nucleic acid sequence based amplification assays (NASBA), transcription mediated amplification (TMA), or computerized detection matrix.

### Claim 13 (depends on 1)

The method of claim 1, wherein the subject has cancer selected from the group consisting of breast cancer, endometrial cancer, ovarian cancer, epithelial ovarian cancer, lung cancer, prostate cancer, kidney cancer, bladder cancer, cancer of the oral mucosa, oesophageal cancer, cancer of the lymphreticular system, brain cancer, genito-urinary cancer, skin cancer, colon cancer, stomach cancer, bladder cancer, cancer of the urethra and cancer of the aerodigestive tract.

### Claim 14 (depends on 1)

The method of claim 1, wherein the first and the second biomarker can be measured sequentially or concurrently.

### Claim 15 (depends on 1)

The method of claim 1, wherein the level of the first biomarker is measured before measuring the level of the second biomarker.

### Claim 16 (depends on 2)

The method of claim 2, further comprising assessing the level of a third biomarker selected from at least one of geminin, Aurora A, Plk1 and
H3S10ph in the biological sample from said subject, wherein the second and third biomarkers are different.

### Claim 17 (depends on 3)

The method of claim 3, further comprising assessing the level of a third biomarker selected from at least one of geminin, Aurora A, Plk1 and
H3S10ph in the biological sample from said subject, wherein the second and third biomarkers are different.

### Claim 18 (depends on 2)

The method of claim 2, wherein the subject has cancer selected from the group consisting of breast cancer, endometrial cancer, ovarian cancer, epithelial ovarian cancer, lung cancer, prostate cancer, kidney cancer, bladder cancer, cancer of the oral mucosa, oesophageal cancer, cancer of the lymphreticular system, brain cancer, genito-urinary cancer, skin cancer, colon cancer, stomach cancer, bladder cancer, cancer of the urethra and cancer of the aerodigestive tract.

### Claim 19 (depends on 3)

The method of claim 3, wherein the subject has cancer selected from the group consisting of breast cancer, endometrial cancer, ovarian cancer, epithelial ovarian cancer, lung cancer, prostate cancer, kidney cancer, bladder cancer, cancer of the oral mucosa, oesophageal cancer, cancer of the lymphreticular system, brain cancer, genito-urinary cancer, skin cancer, colon cancer, stomach cancer, bladder cancer, cancer of the urethra and cancer of the aerodigestive tract.