DIAGNOSIS OF PULMONARY AND/OR CARDIOVASCULAR DISEASE

• US 20100055683A1
• Filed: 05/02/2007
• Published: 03/04/2010
• Est. Priority Date: 05/02/2006
• Status: Abandoned Application

• Current Assignee: Critical Care Diagnostics Inc.
• Original Assignee: Critical Care Diagnostics Inc.
• Inventors: Jacobson, Sven, Snider, James V.
• Application Number:
  US12/299,282
• Publication Number:
  US 20100055683A1
• Time in Patent Office: Days
• US Class Current: 435/6
• CPC Class Codes: C07K 14/54 Interleukins [IL]
• CPC Class Codes: C07K 14/58 Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Cardionatrin; Cardiodilatin
• CPC Class Codes: C07K 14/7155 for interleukins [IL]
• CPC Class Codes: C12Q 1/6883 for diseases caused by alterations of genetic material
• CPC Class Codes: G01N 2333/58 Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Brain natriuretic peptide [BNP, proBNP]; Cardionatrin; Cardiodilatin
• CPC Class Codes: G01N 2800/12 Pulmonary diseases
• CPC Class Codes: G01N 2800/32 Cardiovascular disorders
• CPC Class Codes: G01N 33/53 Immunoassay; Biospecific binding assay; Materials therefor
• CPC Class Codes: G01N 33/6869 Interleukin
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: G01N 33/74 involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
• CPC Class Codes: Y10T 436/143333 Saccharide [e.g., DNA, etc.]

Abstract

Described are methods and kits for determining the likelihood of the presence of cardiovascular disease (CVD) or pulmonary disease (PD) in a subject using ST2/Interleukin 1 Receptor Like 1 (IL1RL1) and/or Interleukin 33 (IL-33), and a biomarker for CVD, e.g., a natriuretic peptide, e.g., brain natriuretic peptide (BNP), prohormone BNP (proBNP), N-Terminal proBNP (NT-proBNP), atrial natriuretic peptide (ANP), proANP, or NT-proANP.

Claims

1. A kit for determining the likelihood of the presence of cardiovascular disease (CVD) or pulmonary disease (PD) in a subject, the kit comprising (i) one or both of a binding composition that specifically binds to IL-33 and a binding composition that specifically binds to ST2, (ii) a binding composition that specifically binds to a biomarker for CVD, and (iii) instructions for use in a method of determining the likelihood of the presence of CVD or PD in a subject, the method comprising:

determining a level of one or both of IL-33 and ST2 in a sample from a subject;

determining a level of a biomarker for CVD in the sample; and

comparing the level of IL-33 or ST-2, and the level of the CVD biomarker, in the sample to preselected corresponding reference levels;

wherein the levels in the sample as compared to the reference levels is correlated with the likelihood of the presence of CVD or PD.

2. The kit of claim 1, wherein the IL-33 and/or ST2 and the CVD biomarker comprise polypeptides, and the binding composition comprises an antibody or antigen binding fragment thereof that binds specifically to the polypeptides.

3. The kit of claim 1, wherein the IL-33 and/or ST2 and the CVD biomarker comprise nucleic acids and the binding composition comprises a probe that binds specifically to nucleic acid.

4. The kit of claim 1, wherein the CVD biomarker is a natriuretic peptide selected from the group consisting of brain natriuretic peptide (BNP), prohormone BNP (proBNP), N-terminal proBNP (NT-proBNP), atrial natriuretic peptide (ANP), proANP, or NT-proANP.

16. The kit of claim 1, wherein the CVD is acute coronary syndrome (ACS), myocardial infarction, heart failure, angina, cardiac hypertrophy, arteriosclerosis, myocarditis, pericarditis, endocarditis, or stroke.

17. The kit of claim 1, wherein the PD is chronic obstructive pulmonary disease (COPD), asthma, pneumonia, pneumothorax, pulmonary embolism, pleural effusion, metastatic disease, pulmonary edema, gastroesophageal reflux disease with aspiration, pulmonary embolism, and restrictive lung disease.

5. A method of determining the likelihood of the presence of cardiovascular disease (CVD) or pulmonary disease (PD) in a subject, the method comprising:

determining a level of a first biomarker selected from the group consisting of IL-33 and ST2 in a sample from a subject;

determining a level of a second biomarker for CVD in the sample; and

comparing the level of the first biomarker and second CVD biomarker in the sample to preselected corresponding reference levels;

wherein the levels of the biomarkers in the sample as compared to the reference levels is correlated with the likelihood of the presence of CVD or PD.

6. The method of claim 5, wherein the subject has chest pain or dyspnea.

7. The method of claim 5, wherein the CVD biomarker is a natriuretic peptide selected from the group consisting of brain natriuretic peptide (BNP), prohormone BNP (proBNP), N-terminal proBNP (NT-proBNP), atrial natriuretic peptide (ANP), proANP, or NT-proANP.

8. The method of claim 5, wherein determining a level of IL-33 in the sample comprises determining a level of one, two, or all three of mature IL-33, pre-IL-33, and pro-IL-33.

9. The method of claim 5, wherein the sample comprises blood, serum, plasma, urine, or body tissue.

10. The method of claim 5, wherein the reference levels represent a level in a subject who has a high likelihood of having pulmonary disease.

11. The method of claim 5, wherein the reference levels represent a level in a subject who has a high likelihood of having cardiovascular disease.

12. The method of claim 5, wherein the reference levels represent a level in a subject with a known severity of cardiovascular or pulmonary disease.

13. The method of claim 5, wherein determining a level of a biomarker in the sample comprises contacting a binding composition to the sample, wherein the binding composition specifically binds to the biomarker, and measuring or determining the specific binding of the binding composition to the sample.

14. The method of claim 13, wherein the binding composition comprises an antibody that binds specifically to a biomarker comprising a polypeptide.

15. The method of claim 13, wherein the binding composition comprises an oligonucleotide probe that bind specifically to a biomarker comprising a polynucleotide.

18. The method of claim 5, further comprising determining a level in the sample of each of one or more other biomarkers.

19. The method of claim 18, wherein the one or more other biomarkers are selected from the group consisting of troponin, creatine kinase MB (CK-MB), ischemia-modified albumin (IMA), Interleukin-6 (IL-6), C-reactive protein (CRP), creatinine, D-dimers, blood urea nitrogen (BUN), liver function enzymes, albumin, and bacterial endotoxin.

20. The kit of method of claim 5, wherein the CVD is acute coronary syndrome (ACS), myocardial infarction, heart failure, angina, cardiac hypertrophy, arteriosclerosis, myocarditis, pericarditis, endocarditis, or stroke.

21. The method of claim 5, wherein the PD is chronic obstructive pulmonary disease (COPD), asthma, pneumonia, pneumothorax, pulmonary embolism, pleural effusion, metastatic disease, pulmonary edema, gastroesophageal reflux disease with aspiration, pulmonary embolism, and restrictive lung disease.