# US 8,771,968 B2 · Biomarker for osteoarthritis and/or other ageing-related diseases, and use thereof

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- Number: US 8,771,968 B2
- Document ID: US8771968B2
- Status: Granted
- Kind: B2
- Application number: 12/737,051
- Filed: 2009-02-27
- Published: 2011-06-30
- Granted: 2014-07-08
- Earliest claimed: 2008-06-03
- Assignees: Universite De Liege
- Applicants: Yves Henrotin; Myriam Gharbi; Michelle Deberg; Edwin De Pauw
- Inventors: Yves Henrotin; Myriam Gharbi; Michelle Deberg; Edwin De Pauw
- Web page: https://patentgrep.com/patent/US8771968B2

## CPC

- G01N 33/564: for pre-existing immune complex or autoimmune disease {, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9}
- G01N 33/6887: {from muscle, cartilage or connective tissue}
- G01N 2333/78: Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
- G01N 2800/105: Osteoarthritis, e.g. cartilage alteration, hypertrophy of bone
- 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)

## Abstract

The invention relates to the identification of a biomarker whose abundance in biological sample is changed in subjects with osteoarthritis and/or other ageing-related diseases. The biomarker has applications in the diagnosis of osteoarthritis and/or other ageing-related diseases, in determining the prognosis for an individual diagnosed with osteoarthritis and/or other ageing-related diseases, and in monitoring the efficacy of treatment for osteoarthritis and/or other ageing-related diseases.

## Claims

### Claim 1

A method of determining the osteoarthritis status of a subject, and/or the status of another ageing-related disease in a subject, comprising the steps of:
(i) determining the concentration in a biological sample of a free fragment consisting of amino acid sequence SEQ ID NO:1;
(ii) comparing the free fragment concentration determined in step (i) with one or more reference values to determine the osteoarthritis status and/or the status of another ageing-related disease in the subject.

### Claim 2

A method of diagnosing osteoarthritis and/or another ageing-related disease in a subject, comprising the steps of:
(i) determining the concentration in a biological sample of a free fragment consisting of amino acid sequence SEQ ID NO:1;
(ii) comparing the peptide concentration determined in step (i) with one or more reference values to determine the osteoarthritis status and/or the status of another ageing-related disease in the subject.

### Claim 3

A method of determining the prognosis for a subject with osteoarthritis and/or another ageing-related disease, comprising the steps of:
(i) determining the concentration in a biological sample of a free fragment consisting of amino acid sequence SEQ ID NO:1;
(ii) comparing the free fragment concentration determined in step (i) with one or more reference values to determine the osteoarthritis status and/or the status of another ageing-related disease in the subject.

### Claim 4 (depends on 1)

The method of claim 1, wherein, prior to and after the following steps, the steps (i) and (ii) are performed:
(A) administering a treatment for osteoarthritis and/or another ageing related disease to the subject;
(B) providing a biological sample from the subject after administration of the treatment.

### Claim 5 (depends on 1)

The method of claim 1 wherein the biological sample is selected from the group comprising urine, whole blood, blood serum, blood plasma, synovium, sweat, cerebrospinal fluid, mucous, saliva, lymph, bronchial aspirates and milk.

### Claim 6 (depends on 1)

The method of claim 1 wherein the concentration of the free fragment is determined by using an immunoassay.

### Claim 7 (depends on 1)

The method of claim 1 wherein the reference value is the concentration of the free fragment in one or more normal subjects.

### Claim 8

A kit for use in determining the osteoarthritis status, or the status of another ageing-related disease, in a subject comprising at least one agent for determining the concentration of a free fragment consisting of amino acid sequence of Seq ID No:1, in a biological sample.

### Claim 9 (depends on 8)

The kit according to claim 8 wherein the agent is selected from the group comprising an enzyme, an antibody, a protein probe, a metabolite or any other suitable composition.

### Claim 10 (depends on 8)

The kit according to claim 8 wherein the agent comprises two antibodies directed to different epitopes on the free fragment.

### Claim 11 (depends on 10)

The kit according to claim 10 for use in determining the concentration of the free fragment by using a sandwich immunoassay.

### Claim 12

An isolated free fragment which consists of amino acid sequence of SEQ ID NO: 1, or its amide, or a salt thereof.
