US2010143954A1PendingUtilityA1
Galectin-3 Immunoassay
Est. expiryOct 29, 2028(~2.3 yrs left)· nominal 20-yr term from priority
Inventors:Pieter Muntendam
G01N 2333/4724G01N 33/6893G01N 2800/325G01N 33/68G01N 33/577C07K 16/2851G01N 33/53C07K 16/18
60
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Claims
Abstract
The present invention relates to methods and compositions for specifically and quantitatively detecting galectin-3 in a sample. Embodiments of the invention include a detection assay in which a capture binding moiety and a labeled binding moiety specifically recognize non-overlapping epitopes on the N-terminus of galectin-3. Further embodiments are directed to a method for establishing ranges of galectin-3 concentrations indicative of the presence and severity of heart failure in a subject and a method for predicting the clinical outcome of a subject based upon galectin-3 concentration.
Claims
exact text as granted — not AI-modified1 . A kit for detecting the concentration of galectin-3 in a sample, the kit comprising
first and second binding moieties, one being labeled with a detectable label, each binding respectively to spaced-apart epitopes on the N-terminal portion of galectin-3, which comprises the sequence of amino acids:
(SEQ ID NO: 1)
MADNFSLHDA LSGSGNPNPQ GWPGAWGNQP AGAGGYPGAS
YPGAYPGQAP PGAYPGQAPP GAYPGAPGAY PGAPAPGVYP
GPPSGPGAYP SSGQPSATGA YPATGPYGAP AGP.
2 . The kit of claim 1 wherein the detectable label is an enzyme or a fluorophore.
3 . The kit of claim 1 wherein the binding moieties respectively bind to an epitope defined by at least a portion of a galectin-3 amino acid sequence selected from the group consisting of:
MADNFSLHDALS,
(amino acids 1-12 of SEQ ID
NO: 1)
MADNFSLHDALSGS,
(amino acids 1-14 of SEQ ID
NO: 1)
GNPNPQGWPGA,
(amino acids 15-25 of SEQ ID
NO: 1)
WGNQPAGAGG,
(amino acids 26-35 of SEQ ID
NO: 1)
YPGQAPPGAYPGQAPPGA,
(amino acids 45-62 of SEQ ID
NO: 1)
YPGAPGAYPGAPAPGV,
(amino acids 63-78 of SEQ ID
NO: 1)
YPGAPAPGVYPGPPSGPGA,
(amino acids 70-88 of SEQ ID
NO: 1)
and
YPSSGQPSATGA.
(amino acids 89-100 of SEQ
ID NO: 1)
4 . The kit of claim 1 wherein the binding moieties are monoclonal antibodies.
5 . The kit of claim 4 wherein the monoclonal antibodies are selected from the group consisting of 9H3.2, 87B5, and M3/38.
6 . The kit of claim 4 , wherein the antibody binds to an epitope comprising MADNFSLHDALSGS (amino acids 1-14 of SEQ ID NO:1), GNPNPQGWPGA (amino acids 15-25 of SEQ ID NO:1), or YPGAPAPGVYPGPPSGPGA (amino acids 70-88 of SEQ ID NO:1).
7 . The kit of claim 4 , wherein the monoclonal antibody is a mouse antibody.
8 . A method for detecting the level of human galectin-3 in a sample from a subject, the method comprising:
subjecting the sample to a double binding moiety sandwich assay, at least one of the binding moieties being labeled with a detectable label, each of the binding moieties being specific for respective, non-overlapping epitopes on the N-terminal portion of galectin-3, which comprises the sequence of amino acids:
(SEQ ID NO: 1)
MADNFSLHDA LSGSGNPNPQ GWPGAWGNQP AGAGGYPGAS
YPGAYPGQAP PGAYPGQAPP GAYPGAPGAY PGAPAPGVYP
GPPSGPGAYP SSGQPSATGA YPATGPYGAP AGP.
9 . The method of claim 8 , wherein the sandwich assay provides a qualitative result indicative of the presence or absence of a galectin-3 concentration above a threshold.
10 . The method of claim 9 , wherein the threshold galectin-3 concentration in the sample from the subject is in the range of 15-20 ng/ml.
11 . The method of claim 9 , wherein the threshold galectin-3 concentration in the sample from the subject is in the range of 20-25 ng/ml.
12 . The method of claim 9 , wherein the threshold galectin-3 concentration in the sample from the subject is in the range of 25-30 ng/ml.
13 . The method of claim 9 , wherein the threshold galectin-3 concentration in the sample from the subject is in the range of 30-35 ng/ml.
14 . The method of claim 8 , wherein the sandwich assay provides a quantitative result indicative of the galectin-3 concentration.
15 . The method of claim 8 comprising the additional step of comparing the result of the sandwich assay to data correlating the concentration of galectin-3 in the sample with data relating the result with risk of the subject developing symptoms of heart failure (HF) or with severity of diagnosed HF disease of the subject.
16 . The method of claim 8 , further comprising repeating over time to obtain a trend.
17 . A method for detecting a risk of development or progression of heart failure in a subject, the method comprising determining whether the galectin-3 concentration in a sample from the subject exceeds a threshold of at least 15 ng/ml.
18 . The method of claim 17 , wherein the threshold is in the range of 15-20 ng/ml.
19 . The method of claim 17 , wherein the threshold is in the range of 20-25 ng/ml.
20 . The method of claim 17 , wherein the threshold is in the range of 25-30 ng/ml.
21 . The method of claim 17 , wherein the threshold is in the range of 30-35 ng/ml.Join the waitlist — get patent alerts
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