# US 10,767,230 B2 · MicroRNA biomarker for the diagnosis and treatment of gastric cancer

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- Number: US 10,767,230 B2
- Document ID: US10767230B2
- Status: Granted
- Kind: B2
- Application number: 15/501,691
- Filed: 2015-08-11
- Published: 2017-08-17
- Granted: 2020-09-08
- Earliest claimed: 2014-08-07
- Assignees: Agency for Science, Technology and Research; National University of Singapore; National University Hospital (Singapore) Pte Ltd
- Applicants: Agency for Science, Technology and Research; National University of Singapore; National University Hospital (Singapore) Pte Ltd
- Inventors: Heng-phon Too; Lihan Zhou; Ruiyang Zou; Khay Guan Yeoh; Bok Yan So; Feng Zhu; Wei Peng Yong
- Web page: https://patentgrep.com/patent/US10767230B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- G01N 33/57557: {of other specific parts of the body, e.g. brain}
- G16B 20/00: ICT specially adapted for functional genomics or proteomics, e.g. genotype-phenotype associations
- G16B 20/20: Allele or variant detection, e.g. single nucleotide polymorphism [SNP] detection
- G16B 25/00: ICT specially adapted for hybridisation; ICT specially adapted for gene or protein expression
- G16B 25/10: Gene or protein expression profiling; Expression-ratio estimation or normalisation
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/112: Disease subtyping, staging or classification
- C12Q 2600/118: Prognosis of disease development
- C12Q 2600/158: Expression markers
- C12Q 2600/16: Primer sets for multiplex assays
- C12Q 2600/178: miRNA, siRNA or ncRNA
- G01N 2800/50: Determining the risk of developing a 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
- 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)
- G16B: BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Disclosed are methods of determining the likelihood of a subject having or developing a gastric cancer. The methods comprise measuring the expression level of at least one miRNA having at least 90% sequence identity with an miRNA as described herein in a non-cellular biofluid sample obtained from the subject, wherein differential expression of miRNA expression in the sample obtained from the subject, as compared to a control, may be indicative of the subject having gastric cancer and wherein the miRNA may be either an miRNA listed as “up-regulated” or an miRNA listed as “down-regulated”. Also disclosed is a method of determining the likelihood of a subject having or developing a stage of a gastric cancer.

## Claims

### Claim 1

A method of treating a gastric cancer, wherein the method comprises:
a) detecting or diagnosing a gastric cancer in a subject or determining a likelihood of a subject having said gastric cancer, wherein detecting or diagnosing said gastric cancer in the subject or determining the likelihood of the subject having said gastric cancer comprises:
i) determining, in a non-cellular biofluid sample obtained from the subject, the expression level of at least six microRNAs (miRNAs) each having at least 90% sequence identity with an miRNA selected from the group consisting of hsa-miR-21-5p, hsa-miR-103a-3p, hsa-miR-20a-5p, hsa-miR-181a-5p, hsa-miR-142-5p, hsa-miR-27a-5p, hsa-miR-26a-5p, hsa-miR-17-5p, hsa-miR-616-5p, hsa-miR-30a-5p, hsa-miR-532-5p and hsa-miR-30e-5p,
ii) determining differential expression of miRNA in the sample, as compared to a control in order to determine the subject to have said gastric cancer or diagnose the subject as having said gastric cancer or determine the likelihood of the subject to develop said gastric cancer,
wherein the differential expression of miRNA is an upregulation or a downregulation of miRNA expression of the at least six miRNAs and
b) treating the subject determined to have or diagnosed with said gastric cancer or having the likelihood of developing said gastric cancer with an anti-gastric cancer compound or a combination of anti-gastric cancer compounds.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the control is a sample obtained from a gastric cancer free subject.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the at least six miRNAs comprise hsa-miR-21-5p, hsa-miR-103a-3p, hsa-miR-20a-5p, hsa-miR-181a-5p, hsa-miR-142-5p, hsa-miR-27a-5p, hsa-miR-26a-5p, hsa-miR-17-5p, hsa-miR-616-5p, hsa-miR-30a-5p, hsa-miR-532-5p and hsa-miR-30e-5p.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the at least six miRNAs are identical to miRNAs selected from the group consisting of hsa-miR-21-5p, hsa-miR-103a-3p, hsa-miR-20a-5p, hsa-miR-181a-5p, hsa-miR-142-5p, hsa-miR-27a-5p, hsa-miR-26a-5p, hsa-miR-17-5p, hsa-miR-616-5p, hsa-miR-30a-5p, hsa-miR-532-5p and hsa-miR-30e-5p.