# US 10,480,034 B2 · Cancer biomarker and diagnostic

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- Number: US 10,480,034 B2
- Document ID: US10480034B2
- Status: Granted
- Kind: B2
- Application number: 16/166,626
- Filed: 2018-10-22
- Published: 2019-03-28
- Granted: 2019-11-19
- Earliest claimed: 2013-09-20
- Applicants: Jeffrey Lordan
- Inventors: Jeffrey Lordan
- Web page: https://patentgrep.com/patent/US10480034B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- G01N 33/57535: of the large intestine, e.g. colon, rectum or anus
- 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}
- C12Q 2600/112: Disease subtyping, staging or classification
- C12Q 2600/118: Prognosis of disease development
- C12Q 2600/136: Screening for pharmacological compounds
- C12Q 2600/158: Expression markers
- G01N 2333/914: Hydrolases (3)
- G01N 2500/04: Screening involving studying the effect of compounds C directly on molecule A (e.g. C are potential ligands for a receptor A, or potential substrates for an enzyme A)
- 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
- 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 application discloses new biomarkers and methods useful in the diagnosis, prognosis and/or monitoring of, or as a therapeutic or research target for, solid tumour cancers, such as colorectal cancer, based on measuring the biomarkers; and related kits and devices.

## Claims

### Claim 1

A method for the diagnosis and/or prognosis of colorectal cancer, in a subject, wherein the method comprises:
(i) measuring the level of ATP11B gene expression and/or the quantity protein or peptides resulting from ATP11B gene translation in a biological sample from the subject, and
(ii) comparing the level or quantity measured in (i) with a reference value of the level of gene expression or quantity of proteins or peptides resulting from ATP11B gene translation, wherein the reference value represents a constitutive level of the gene expression and/or translation;
wherein either:
a) gene expression level or protein/peptide quantity at least about 40% (about 1.4-fold or more) above the reference value is indicative of a solid colorectal tumor, or
b) a gene transcription measurement or protein/peptide quantity substantially at or similar to the reference value indicates that no colorectal cancer tumor is present, and
(iii) treating the subject identified in (ii)(a) as having a solid colorectal tumor by administering radiotherapy or chemotherapy or carrying out surgery, or a combination thereof.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the method further comprises measuring the level of S100A11 gene expression and/or the quantity protein or peptides resulting from S100A11 gene translation and the quantity measured is compared with a reference value of the level of gene expression or quantity of proteins or peptides resulting from S100A11 gene translation, wherein the reference value represents a constitutive level of the gene expression and/or translation.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the reference value(s) is obtained from a population that is free from a colorectal cancer.

### Claim 4

A method for treating colorectal cancer in a subject in need of said treatment, the method comprising:
a) identifying the subject as in need of treatment for colorectal cancer by a method comprising:
(i) measuring the level of ATP11B gene expression and/or the quantity protein or peptides resulting from ATP11B gene translation in a biological sample from the subject, and
(ii) comparing the level or quantity measured in (i) with a reference value of the level of gene expression and/or the quantity of proteins or peptides resulting from ATP11B gene translation, wherein the reference value represents a constitutive level of the gene expression and/or translation;
wherein a) an increased gene expression level or protein/peptide quantity at least about 40% (about 1.4-fold or more) above the reference value is indicative of a colorectal cancer tumor and identifies the subject as in need of treatment, and
b) treating the subject identified as in need of treatment by administering radiotherapy or chemotherapy or carrying out surgery, or a combination thereof.

### Claim 5 (depends on 4)

The method according to claim 4, wherein the method further comprises measuring the level of S100A11 gene expression and/or the quantity protein or peptides resulting from S100A11 gene translation and the quantity measured is compared with a reference value of the level of gene expression or quantity of proteins or peptides resulting from S100A11 gene translation, wherein the reference value represents a constitutive level of the gene expression and/or translation.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the protein or peptides resulting from ATP11B gene translation is a P-type ATPase.

### Claim 7 (depends on 6)

The method according to claim 6, wherein the P-type ATPase is Probable phospholipid-transporting ATPase IF.

### Claim 8 (depends on 2)

The method according to claim 2, wherein the protein or peptides resulting from S100A11 gene translation is 5100 calcium binding protein A11 (calgizzarin).

### Claim 9 (depends on 1)

The method according to claim 1, wherein the biological sample is blood, plasma, serum, saliva or a tissue biopsy.

### Claim 10 (depends on 1)

The use according to claim 1, wherein the level quantity of the one or more markers, is measured using an immunoassay technology, a mass spectrometry analysis method, a chromatography method, or a combination of such methods.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the measuring step is performed by an immunoassay technology, a mass spectrometry analysis method, a chromatography method, or a combination of such methods.

### Claim 12 (depends on 4)

The method according to claim 4, wherein the protein or peptides resulting from ATP11B gene translation is a P-type ATPase.

### Claim 13 (depends on 12)

The method according to claim 12, wherein the P-type ATPase is Probable phospholipid-transporting ATPase IF.

### Claim 14 (depends on 5)

The method according to claim 5, wherein the protein or peptides resulting from S100A11 gene translation is 5100 calcium binding protein A11 (calgizzarin).

### Claim 15 (depends on 4)

The method according to claim 4, wherein the biological sample is blood, plasma, serum, saliva or a tissue biopsy.

### Claim 16 (depends on 4)

The method according to claim 4, wherein the measuring step is performed by an immunoassay technology, a mass spectrometry analysis method, a chromatography method, or a combination of such methods.