IP Library › Granted Patent US 10,234,462
Granted Patent B2
US 10,234,462 · App. 13/359,276 · Granted Mar 19, 2019

Use of mimecan in the assessment of heart failure

Inventors: Dirk Block (Bichl, DE); Sara Arab (Toronto, CA); Georg Hess (Mainz, DE); Hendrik Huedig (Penzberg, DE); Peter Liu (Toronto, CA); Ursula-Henrike Wienhues-Thelen (Krailing, DE)
Assignee: Roche Diagnostics Operations, Inc.
G01N33/6893G01N33/6812G01N2333/4703G01N2800/325
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Quick Facts
Patent No.
US 10,234,462
App. No.
13/359,276
Granted
Mar 19, 2019
Kind
B2
Abstract

The disclosure relates to assessing heart failure in vitro by measuring the concentration of the marker mimecan in a sample, and optionally measuring in the sample the concentration of one or more other marker(s) of heart failure, and of assessing heart failure by comparing the concentration of mimecan and the one or more other marker(s) to reference concentrations of this (or these) marker(s) as established in a reference population. The one or more markers may be selected from the group comprising a natriuretic peptide marker, a cardiac troponin marker, and a marker of inflammation. Also disclosed are the use of mimecan as a marker protein in the assessment of heart failure, a marker combination comprising mimecan, and a kit for measuring mimecan.

Claims (25)

1. A method of diagnosing heart failure in an individual suspected of having heart failure, the method comprising the steps of:

contacting, in-vitro, a portion of a sample from the individual with an antibody or fragment thereof having specific binding affinity for a marker mimecan having an amino acid sequence at least 90% identical to SEQ ID NO: 1, thereby forming a complex between the antibody or fragment thereof and the marker mimecan present in the sample, the antibody having a detectable label, the sample comprising one of serum, plasma and whole blood;

separating the complex formed in said step of contacting from antibody or fragment thereof not comprising the complex;

quantifying a signal from the detectable label of the antibody or fragment thereof comprising the complex formed in said step of contacting, the signal being proportional to an amount of the marker mimecan present in the sample of the individual, whereby a concentration of the marker mimecan within the sample of the individual based on the quantified signal calculated;

comparing the calculated concentration value of the marker mimecan within the sample of the individual determined in said step of quantifying to an established diagnostic reference concentration of the marker mimecan, the reference concentration of the marker mimecan set at 90% specificity; and

providing a diagnosis of heart failure in the individual if the calculated concentration value of the marker mimecan is greater than the established diagnostic reference concentration of the marker mimecan.

2. The method according to claim 1 , wherein said step of contacting comprises an enzyme-linked immunosorbent assay application.

3. The method according to claim 1 further comprising the steps of:

contacting, in-vitro, a portion of a sample from an individual with an antibody or fragment thereof having specific binding affinity for one of a natriuretic peptide marker, a cardiac troponin marker, and a marker of inflammation;

calculating a concentration of the one of the natriuretic peptide marker, the cardiac troponin marker, and the marker of inflammation within the sample based on said step of contacting; and

comparing the concentration of the one of the natriuretic peptide marker, the cardiac troponin marker, and the marker of inflammation determined in said step of calculating to a reference concentration of the one of the natriuretic peptide marker, the cardiac troponin marker, and the marker of inflammation, respectively,

wherein said step of providing comprises providing a diagnosis of heart failure if the concentration of the marker mimecan determined in said step of calculating is greater than the reference concentration of the marker mimecan and the concentration of the one of the natriuretic peptide marker, the cardiac troponin marker, and the marker of inflammation determined in said calculating is greater than the reference concentration for the one of the natriuretic peptide marker, the cardiac troponin marker, and the marker of inflammation determined in said calculating, respectively.

4. The method of claim 3 , wherein the reference concentration of the marker mimecan and the one of the natriuretic peptide marker, the cardiac troponin marker, and the marker of inflammation are established in a same control sample.

5. The method according to claim 3 , further characterized in that the at least one additional marker is NT-proBNP.

6. The method according to claim 3 , further characterized in that the at least one additional marker is troponin T.

7. The method of claim 1 , wherein the reference concentration of the marker mimecan is established in a control sample.

8. The method of claim 7 , further comprising the steps of:

contacting, in-vitro, a portion of the control sample with the antibody or fragment thereof having specific binding affinity for the marker mimecan; and

calculating the reference concentration of the marker mimecan within the control sample based on said step of contacting.

9. The method according to claim 8 , wherein the control sample comprises a body fluid.

10. The method according to claim 9 , wherein the body fluid is selected from the group consisting of plasma, whole blood, and serum.

11. The method according to claim 8 , wherein said step of calculating the reference concentration is performed concurrently with said step of calculating the concentration of the marker mimecan.

12. The method of claim 1 , wherein said step of quantifying the signal comprises use of a computing device.

13. The method of claim 1 , wherein said step of providing a diagnosis comprises use of a computing device.

14. The method of claim 1 , wherein said step of providing a diagnosis comprises providing a diagnosis of heart failure in the individual only if the concentration of the marker mimecan determined in said step of quantifying is 1.5 times greater than the reference concentration of the marker mimecan.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 28, 2012
From: BLOCK, DIRK; HESS, GEORG; HUEDIG, HENDRIK; WIENHUES-THELEN, URSULA-HENRIKE
To: ROCHE DIAGNOSTICS GMBH
Reel/Frame 027771/0407 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 28, 2012
From: ARAB, SARA; LIU, PETER
To: THE GOVERNING COUNCIL OF THE UNIVERSITY OF TORONTO
Reel/Frame 027771/0429 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 28, 2012
From: ROCHE DIAGNOSTICS GMBH
To: ROCHE DIAGNOSTICS OPERATIONS, INC.
Reel/Frame 027771/0459 →
Priority Claims (1)
EP 09009666 · Jul 27, 2009 · regional
Continuity (2)
Continuation PCTEP2010004521 · Jul 23, 2010
Related Publication 20120156703A1 · Jun 21, 2012
Cited By (2)
US 12,322,100 US 12,400,762