# US 10,370,720 B2 · Kit and method for detecting bladder cancer

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- Number: US 10,370,720 B2
- Document ID: US10370720B2
- Status: Granted
- Kind: B2
- Application number: 15/118,266
- Filed: 2015-02-11
- Published: 2016-12-15
- Granted: 2019-08-06
- Earliest claimed: 2014-02-12
- Assignees: Leica Biosystems Newcastle Ltd.
- Applicants: Leica Biosystems Newcastle Ltd.
- Inventors: Saskia Schoenmakers; Harry Schrickx; Herman Volkers
- Web page: https://patentgrep.com/patent/US10370720B2

## CPC

- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- C12Q 1/68: involving nucleic acids
- C12Q 1/6841: In situ hybridisation
- C12Q 2600/118: Prognosis of disease development
- 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

Methods and kits are provided for screening a patient for bladder cancer. Embodiments include those involving centromeric probes to chromosomes 3, 7, and 10 and a locus-specific probe to 5p15.

## Claims

### Claim 1

A method of hybridization to a set of probes in a patient with bladder cancer, said method comprising:
hybridizing the set of probes to (i) more than two copies of two or more of the centromeric regions of the chromosomes 3, 7, and 10 or (ii) more than two copies of the 5p15 region in a biological sample from the patient, wherein the set consists of centromeric probes to chromosomes 3, 7, and 10 and a locus-specific probe to 5p15 that specifically binds TERT or CLPTM1L.

### Claim 2 (depends on 1)

The method of claim 1, wherein the biological sample is selected from the group consisting of urine, bladder washings, tissue samples, touch preps, and fine-needle aspirates.

### Claim 3 (depends on 2)

The method of claim 2, wherein the biological sample is urine.

### Claim 4 (depends on 1)

The method of claim 1, wherein each probe is labeled.

### Claim 5 (depends on 4)

The method of claim 4, wherein at least one probe is fluorescently labeled.

### Claim 6 (depends on 1)

The method of claim 1, wherein the locus-specific probe to 5p15 binds to TERT.

### Claim 7 (depends on 1)

The method of claim 1, wherein the locus-specific probe to 5p15 targets a genomic region that is about 150-250 kb.

### Claim 8 (depends on 1)

The method of claim 1, wherein the locus-specific probe to 5p15 targets a genomic region that is about 190-210 kb.

### Claim 9 (depends on 1)

The method of claim 1, wherein the locus-specific probe to 5p15 is depleted of repetitive sequences.

### Claim 10 (depends on 1)

The method of claim 1, wherein the locus-specific probe to 5p15 contains repetitive sequences.

### Claim 11 (depends on 1)

The method of claim 1, wherein the centromeric probes are satellite enumeration probes.