# US 2008/0188004 A1 · Assay for diabetes

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- Number: US 2008/0188004 A1
- Document ID: US20080188004A1
- Status: Published application
- Kind: A1
- Application number: 12/035,290
- Filed: 2008-02-21
- Published: 2008-08-07
- Earliest claimed: 2003-09-03
- Assignees: Minomic Pty Ltd
- Inventors: Bradley John Walsh; Geoffrey Bruce Randall; Steven Brian Wilson
- Web page: https://patentgrep.com/patent/US20080188004A1

## CPC

- G01N 33/6893: {related to diseases not provided for elsewhere}
- C07K 14/775: Apolipopeptides
- C07K 14/8107: {Endopeptidase (E.C. 3.4.21-99) inhibitors}
- G01N 33/686: {Anti-idiotype}
- G01N 33/92: involving lipids, e.g. cholesterol {, lipoproteins, or their receptors (steroid hormones G01N33/743)}
- G01N 2800/042: Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
- 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)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)

## Abstract

An assay for testing a subject for diabetes or a predisposition to diabetes including analyzing a biological fluid from a subject for the presence of one or more proteins selected from the group consisting of Alpha 2 macroglobulin, Apolipoprotein AII, Immunoglobulin alpha heavy chain constant region, Immunoglobulin mu chain C region, Chain A of Human IgA1, Inter-alpha-trypsin inhibitor heavy chain H4 precursor, and Apolipoprotein B11; wherein detection of the protein is indicative of diabetes or a predisposition to diabetes in the subject.

## Claims

### Claim 1

An assay for testing a subject for diabetes or a predisposition to diabetes comprising:
analyzing a biological fluid from a subject for the presence of one or more proteins selected from the group consisting of Alpha 2 macroglobulin, Apolipoprotein A1, Immunoglobulin alpha heavy chain constant region, Immunoglobulin mu chain C region, Chain A of Human IgA1, Inter-alpha-trypsin inhibitor heavy chain H4 precursor, and Apolipoprotein B-100;
wherein detection of the protein is indicative of diabetes or a predisposition to diabetes in the subject.

### Claim 2 (depends on 1)

The assay according to claim 1 wherein the one or more proteins are detected by the presence of a peptide marker selected from the group consisting of:
AYIFIDEAHITQALIWLSQR,
(SEQ ID NO: 1)
LLIYAVLPTGDVIGDSAK,
(SEQ ID NO: 2)
LLLQQVSLPELPGEYSMK,
(SEQ ID NO: 3)
QGLLPVLESFK,
(SEQ ID NO: 4)
LLDNWDSVTSTFSK,
(SEQ ID NO: 5)
KEPSQGTTTFAVTSILR,
(SEQ ID NO: 6)
VFAIPPSFASIFLTK,
(SEQ ID NO: 7)
QEPSQGTTTFAVTSILR,
(SEQ ID NO: 8)
WLQGSQELPR,
(SEQ ID NO: 9)
LWAYLTIQQLLEQTVSASDADQQALR,
(SEQ ID NO: 10)
AEAQAQYSAAVAK,
(SEQ ID NO: 11)
YSQPEDSLIPFFEITVPESQLTVSQFTLPK,
(SEQ ID NO: 12)
and
IAIANIIDEIIEK.
(SEQ ID NO: 13)

### Claim 3 (depends on 1)

The assay according to claim 1 wherein biological fluid is selected from the group consisting of urine, saliva, blood, blood products, serum, plasma, tears, cerebrospinal fluid, and lymph.

### Claim 4 (depends on 3)

The assay according to claim 3 wherein the biological fluid is urine.

### Claim 5 (depends on 1)

The assay according to claim 1 wherein the biological fluid is processed prior to analysis.

### Claim 6 (depends on 5)

The assay according to claim 5 wherein the biological fluid is concentrated by membrane-based electrophoresis, TCA precipitation or acetone precipitation.

### Claim 7 (depends on 1)

The assay according to claim 1 wherein proteins present in the biological fluid are digested to form peptide fragments which are detected by conducting mass spectrophotometric analysis on the digested sample.

### Claim 8 (depends on 1)

The assay according to claim 1 wherein the subject is a human.

### Claim 9

An isolated peptide marker detectable in a biological sample of a subject and being indicative of diabetes or a predisposition to diabetes in a subject comprising one or more of the following amino acid sequences:
AYIFIDEAHITQALIWLSQR,
(SEQ ID NO: 1)
LLLYAVLPTGDVIGDSAK,
(SEQ ID NO: 2)
LLLQQVSLPELPGEYSMK,
(SEQ ID NO: 3)
QGLLPVLESFK,
(SEQ ID NO: 4)
LLDNWDSVTSTFSK,
(SEQ ID NO: 5)
KEPSQGTTTFAVTSILR,
(SEQ ID NO: 6)
VFAIPPSFASIFLTK,
(SEQ ID NO: 7)
QEPSQGTTTFAVTSILR,
(SEQ ID NO: 8)
WLQGSQELPR,
(SEQ ID NO: 9)
LWAYLTIQQLLEQTVSASDADQQALR,
(SEQ ID NO: 10)
AEAQAQYSAAVAK,
(SEQ ID NO: 11)
YSQPEDSLIPFFEITVPESQLTVSQFTLPK,
(SEQ ID NO: 12)
or
IAIANIIDEIIEK.
(SEQ ID NO: 13)

### Claim 10 (depends on 9)

An isolated antibody directed to peptide marker according to claim 9.

### Claim 11 (depends on 10)

The antibody according to claim 10 being a polyclonal antibody.

### Claim 12 (depends on 10)

The antibody according to claim 10 being a monoclonal antibody.

### Claim 13 (depends on 10)

The antibody according claim 10 being detectably labeled.

### Claim 14

An assay for testing a subject for diabetes or a predisposition to diabetes comprising:
obtaining a urine sample from a subject;
concentrating the urine sample;
digesting proteins present in the concentrated urine sample to form peptides;
optionally, separating the peptides; and
analyzing the peptides for the presence of one or marker peptides having an amino acid sequence of any one of SEQ ID NOS:1 to 13, wherein the presence of marker peptides having an amino acid sequence of any one of SEQ ID NOS:1 to 13 is indicative of diabetes or a predisposition to diabetes in the subject.

### Claim 15 (depends on 14)

The assay according to claim 14 wherein the peptides are detected using an antibody directed to a marker peptide having an amino acid sequence of any one of SEQ ID NOS:1 to 13.