# US 2014/0194312 A1 · Complex sets of mirnas as non-invasive biomarkers for dilated cardiomyopathy

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- Number: US 2014/0194312 A1
- Document ID: US20140194312A1
- Status: Published application
- Kind: A1
- Application number: 14/124,264
- Filed: 2012-06-08
- Published: 2014-07-10
- Earliest claimed: 2011-06-08
- Assignees: Comprehensive Biomarker Center GmbH
- Inventors: Andreas Keller; Benjamin Meder; Hugo Katus; Britta Vogel; Markus Beier
- Web page: https://patentgrep.com/patent/US20140194312A1

## CPC

- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 2600/158: Expression markers
- C12Q 2600/178: miRNA, siRNA or ncRNA
- 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 present invention relates to non-invasive methods, kits and means for diagnosing and/or prognosing of dilated cardiomyopathy in a body fluid sample from a subject. Further, the present invention relates to set of polynucleotides or sets of primer pairs for detecting sets of miRNAs for diagnosing and/or prognosing of dilated cardiomyopathy in a body fluid sample from a subject. In addition, the present invention relates to sets of miRNAs for diagnosing and/or prognosing of dilated cardiomyopathy in a body fluid sample from a subject.

## Claims

### Claim 1

A method for diagnosing of dilated cardiomyopathy comprising the steps of:
(i) determining an expression profile of a set comprising at least two miRNAs representative for dilated cardiomyopathy in a blood sample from a subject, and
(ii) comparing said expression profile to a reference, wherein the comparison of said expression profile to said reference allows for the diagnosis and/or prognosis of dilated cardiomyopathy,
wherein the nucleotide sequences of the miRNAs comprised in the set are selected from the group consisting of SEQ ID NO: 1 to 387, a fragment thereof, and a sequence having at least 80% sequence identity thereto.

### Claim 2 (depends on 1)

The method of claim 1, wherein the blood sample is a blood cell sample or a leukocyte containing sample, or a fraction thereof.

### Claim 3 (depends on 2)

The method of claim 2, wherein the miRNAs comprised in the set are selected, from the group consisting of SEQ ID NO: 1, 3, 6, 14, 24, 27, 30, 34.

### Claim 4 (depends on 2)

The method of claim 2, wherein the set of miRNAs comprises at least one of the sets of miRNAs listed in FIG. 3A or 3B.

### Claim at position 5

5-11. (canceled)

### Claim 12

A kit for diagnosing of dilated cardiomyopathy comprising
(i) means for determining an expression profile of a set comprising at least two miRNAs representative for dilated cardiomyopathy in a blood sample from a subject, comprising:
(a) a set of at least two polynucleotides,
wherein the polynucleotides are for detecting a set comprising at least two miRNAs for diagnosing of dilated cardiomyopathy in a blood sample from a subject and wherein the nucleotide sequences of the miRNAs comprised in the set are selected from the group consisting of SEQ ID NO: 1 to 387.
(b) a biochip, a RT-PCT system, a PCR-system, a flow cytometer or a next generation sequencing system
and
(ii) at least one reference.
wherein the nucleotide sequences of said miRNAs are selected from the group consisting of SEQ ID NO: 1 to 387, a fragment thereof, and a sequence having at least 80% sequence identity thereto

### Claim at position 7

13-19. (canceled)

### Claim 20

A method for diagnosing dilated cardiomyopathy and diagnosing the severity of dilated cardiomyopathy comprising the steps of:
(i) determining an expression profile of a set comprising at least two miRNAs representative for dilated cardiomyopathy in a blood sample from a subject, and
(ii) comparing said expression profile to a reference, wherein the comparison of said expression profile to said reference allows for diagnosing dilated cardiomyopathy and diagnosing the severity of dilated cardiomyopathy
wherein the nucleotide sequences of the miRNAs comprised in the set are selected from the group consisting of SEQ ID NO: 1, 3, 6, 14, 24, 30, 34, a fragment thereof, and a sequence having at least 80% sequence identity thereto.

### Claim 21 (depends on 20)

The method of claim 20, wherein the diagnosing dilated cardiomyopathy and diagnosing the severity of dilated cardiomyopathy is carried out simultaneously

### Claim 22 (depends on 20, 21)

The method of claim 20 or 21, wherein the blood sample is a blood cell sample or a leukocyte containing sample, or a fraction thereof.