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US 2021/0080464 A1Published application
SPARC Assay
AssigneeNordic Bioscience A/S
InventorsStephanie Nina Kehlet, Diana Øersnes-Leeming, Morten Karsdal
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Abstract
The present invention relates to an assay for detecting secreted proteome acidic and rich in cysteine (SPARC), and more specifically to its use in evaluating lung cancer.
Claims10
1:
- A method of immunoassay for detecting and/or monitoring progression of lung cancer in a patient, the method comprising contacting a patient biofluid sample with a monoclonal antibody specifically reactive with an N-terminus amino acid sequence LLARDFEKNY (SEQ ID NO:
- 1), wherein the monoclonal antibody does not specifically recognise or bind an N-extended elongated version of said N-terminus amino acid sequence or an N-truncated shortened version of said N-terminus amino acid sequence, determining the amount of binding between said monoclonal antibody and peptides comprising said N-terminus amino acid sequence, and correlating said amount of binding with values associated with normal healthy subjects and/or values associated with known lung cancer severity and/or values obtained from said patient at a previous time point and/or a predetermined cut-off value.
2:
- The method as claimed in claim 1, wherein the predetermined cut-off value is at least 9.0 ng/mL.
3:
- The method of claim 1, wherein the patient biofluid sample is blood, urine, synovial fluid, serum or plasma.
4:
- The method of claim 1, wherein the immunoassay is a competition assay or a sandwich assay.
5:
- The method of claim 1, wherein the immunoassay is an enzyme-linked immunosorbent assay or a radioimmunoassay.
6:
- A method for determining whether a patient is responding positively to a treatment for lung cancer, wherein said method comprises using the method of claim 1 to quantify the amount of peptides comprising the N-terminus amino acid sequence LLARDFEKNY (SEQ ID NO:
- 1) in at least two biological samples, said biological samples having been obtained from said patient at a first time point and at at least one subsequent time point during a period of administration of the treatment to said patient, and wherein a reduction in the quantity of peptides comprising the N-terminus amino acid sequence LLARDFEKNY (SEQ ID NO:
- 1) from said first time point to said at least one subsequent time point during the period of treatment is indicative of said patient responding positively to said treatment.
7:
- A method of immunoassay for detecting and/or monitoring progression of idiopathic pulmonary fibrosis (IPF) in a patient, the method comprising contacting a patient biofluid sample with a monoclonal antibody specifically reactive with an N-terminus amino acid sequence LLARDFEKNY (SEQ ID NO:
- 1), wherein the monoclonal antibody does not specifically recognise or bind an N-extended elongated version of said N-terminus amino acid sequence or an N-truncated shortened version of said N-terminus amino acid sequence, determining the amount of binding between said monoclonal antibody and peptides comprising said N-terminus amino acid sequence, and correlating said amount of binding with values associated with normal healthy subjects and/or values associated with known IPF severity and/or values obtained from said patient at a previous time point and/or a predetermined cut-off value.
8:
- The method of claim 7, wherein the patient biofluid sample is blood, urine, synovial fluid, serum or plasma.
9:
- The method of claim 7, wherein the immunoassay is a competition assay or a sandwich assay.
10:
- The method of claim 7, wherein the immunoassay is an enzyme-linked immunosorbent assay or a radioimmunoassay.