# US 11,352,674 B2 · Multiplexed KRAS mutation detection assay

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- Number: US 11,352,674 B2
- Document ID: US11352674B2
- Status: Granted
- Kind: B2
- Application number: 16/814,798
- Filed: 2020-03-10
- Published: 2020-08-27
- Granted: 2022-06-07
- Earliest claimed: 2011-10-18
- Assignees: Exact Sciences Development Company, LLC
- Applicants: Exact Sciences Development Company, LLC
- Inventors: Rebecca Oldham-Haltom; Hatim Allawi; Hongzhi Zou; Michael J. Domanico; Graham P. Lidgard
- Web page: https://patentgrep.com/patent/US11352674B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- C12Q 1/6858: Allele-specific amplification
- C12Q 2600/156: Polymorphic or mutational markers
- C12Q 2600/16: Primer sets for multiplex assays
- 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

Provided herein is reagent mixture comprising multiplexed amplification reagents and flap assay reagents for detecting, in a single reaction, mutant copies of the KRAS gene that contain any of the 34A, 34C, 34T, 35A, 35C, 35T or 38A point mutations. Methods that employ the reagent mix and kits for performing the same are also provided.

## Claims

### Claim 1

A kit comprising:
at least seven different oligonucleotides, wherein the oligonucleotides each comprise at least 12 contiguous nucleotides from the 3′ end of a sequence as set forth in SEQ ID NOs: 11-17 or their complements, wherein the oligonucleotides are in one or more containers.

### Claim 2 (depends on 1)

The kit of claim 1, wherein the oligonucleotides are in separate containers.

### Claim 3 (depends on 1)

The kit of claim 1, wherein the oligonucleotides are in the same container.

### Claim 4 (depends on 1)

The kit of claim 1, wherein the oligonucleotides each comprise a sequence selected from SEQ ID NOS: 11-17.

### Claim 5 (depends on 1)

The kit of claim 1, wherein the kit further comprises forward and reverse primers that each hybridize to the human KRAS gene.

### Claim 6 (depends on 1)

The kit of claim 1, wherein the kit further comprises a thermostable polymerase.

### Claim 7 (depends on 1)

The kit of claim 1, wherein the kit further comprises deoxynucleotide triphosphates.

### Claim 8

A composition comprising:
at least seven different oligonucleotides, wherein the oligonucleotides each comprise at least 12 contiguous nucleotides from the 3′ end of a sequence as set forth in SEQ ID NOs: 11-17 or their complements.

### Claim 9 (depends on 8)

The composition of claim 8, wherein the oligonucleotides each comprise a sequence selected from SEQ ID NOS: 11-17.

### Claim 10 (depends on 8)

The composition of claim 8, wherein the composition further comprises forward and reverse primers that each hybridize to the human KRAS gene.

### Claim 11 (depends on 8)

The composition of claim 8, wherein the composition further comprises a thermostable polymerase.

### Claim 12 (depends on 8)

The composition of claim 8, wherein the composition further comprises deoxynucleotide triphosphates.