# US 10,370,721 B2 · Method of determining risk of 5-fluorouracil toxicity

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- Number: US 10,370,721 B2
- Document ID: US10370721B2
- Status: Granted
- Kind: B2
- Application number: 15/123,620
- Filed: 2015-03-02
- Published: 2017-03-16
- Granted: 2019-08-06
- Earliest claimed: 2014-03-04
- Assignees: Oxford University Innovation Limited
- Applicants: Oxford University Innovation Limited
- Inventors: David Kerr; Ian Tomlinson; Dan Rosmarin; Claire Palles
- Web page: https://patentgrep.com/patent/US10370721B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- C12Q 2600/106: Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
- C12Q 2600/156: Polymorphic or mutational markers
- C12Q 2600/16: Primer sets for multiplex assays
- C12Q 2600/172: Haplotypes
- 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

## Abstract

The invention provides an assay useful in predicting risk of 5-fluorouracil (FU) toxicity in a subject. The subject may be screened for the presence of at least one TYMS polymorphism and/or at least one DPYD polymorphism. Suitable TYMS and DPYD polymorphisms are provided. The presence of one or more of the polymorphisms indicates an increased risk of developing FU toxicity; a negative result may indicate a decreased risk of developing FU toxicity.

## Claims

### Claim 1

A method, comprising isolating a sample and detecting in the sample by assay (a) a thymidylate synthase (TYMS) polymorphisms rs2612091 and (b) at least one dihydropyrimidine dehydrogenase (DPYD) polymorphism selected from the group consisting of: rs3918290, rs67376798, rs12132152, rs12022243 and substitution of guanine for adenine at coding DNA position 1651 (C.G1651A).

### Claim 2 (depends on 1)

The method according to claim 1, wherein the detecting comprises
detecting the TYMS polymorphism rs2612091; and
detecting DPYD polymorphisms rs3918290, rs67376798, rs12132152, and c.G1651A.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the sample is obtained from a cancer patient.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the sample is obtained from a subject who is undergoing chemotherapy with 5-fluorouracil (FU).

### Claim 5 (depends on 4)

The method according to claim 4, wherein the subject is undergoing capecitabine monotherapy.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the sample is a fluid sample from a patient.

### Claim 7 (depends on 6)

The method according to claim 6, wherein the fluid sample is a saliva, blood serum or plasma sample.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the sample is a solid sample from a patient.

### Claim 9 (depends on 1)

The method of claim 1, wherein the sample is obtained from a patient, and
the method further comprises administering a chemotherapeutic agent that does not comprise 5-fluorouracil.