BIOMARKERS FOR OVARIAN CANCER
The present invention provides protein-based biomarkers and biomarker combinations that am useful in qualifying ovarian cancer status in a patient. In particular, the biomarkers of this invention are useful to classify a subject sample as ovarian cancer, ovarian cancer of low malignant potential, benign ovarian disease or other malignant condition. The biomarkers can be detected by SELDI mass spectrometry.
1 . A method for qualifying ovarian cancer status in a subject comprising:
(a) measuring by immunoassay or mass spectroscopy at least one biomarker in a biological sample selected from blood, serum, plasma, and ovarian cyst fluid from the subject using the composition of claim 32 ; and
(b) correlating the measurement with ovarian cancer status.
2 - 6 . (canceled)
7 . The method of claim 1 L further comprising measuring a biomarker selected from the group consisting of ApoCl, Hemoglobin alpha/beta, ApoAII, ApoCII, Calcyclin, Calgranulin C, Calgranulin C (truncated form), Calgranulin A, IgG heavy chain, CA125 II, CA15-3, CAl 9-9, CA72-4, CA 195, CEA, creatine kinase B (CKB), Dianon NB 70/K, haptoglobin, transthyretin, ITIH4 beta 2-microglobulin, galactosyltransferase, haptoglobin, HE4, hepcidin, HER-2/neu, macrophage colony stimulating factor (M-CSF, CSF-I), prostatin, osteopontin, esoinophil-derived neurotoxin, extracellular domain of the epidermal growth factor receptor (p 11 OEGFR), kallikrein 6 and kallikrein 10, LASA, leptin, lysophosphatidic acid (LPA), placental alkaline phosphatase (PLAP), prolactin, SMRP, insulin-like growth factor L IGF-II, hemoglobin, urinary gonadotropin peptide, Sialyl TN, Tissue peptide antigen (TPA), tumor associated trypsin inhibitor (TATI), and modified forms thereof.
8 - 11 . (canceled)
12 . The method of claim 1 , wherein the correlating is performed by a software classification algorithm.
13 . The method of claim 1 , wherein ovarian cancer status is selected from benign ovarian disease, ovarian cancer of low malignant potential, ovarian cancer and other malignant conditions.
14 - 15 . (canceled)
16 . The method of claim 1 , wherein the ovarian cancer status rules out the possibility of benign ovarian disease or rules out the possibility of ovarian cancer.
17 . (canceled)
18 . The method of claim 1 , further comprising: (c) managing subject treatment based on the status.
19 . The method of claim 1 , further comprising: (c) reporting the status to the subject.
20 . The method of claim 1 , further comprising: (c) recording the status on a tangible medium.
21 - 22 . (canceled)
23 . The method of claim 18 , wherein, if the measurement correlates with ovarian cancer, then managing subject treatment comprises administering a chemotherapeutic agent to the subject.
24 . The method of claim 18 , further comprising: (d) measuring the at least one biomarker after subject management and correlating the measurement with disease progression.
25 - 31 . (canceled)
32 . A composition comprising CA125, HE4, transferrin, and ApoA1 for qualifying ovarian cancer in a subject.
33 . A composition for qualifying ovarian cancer comprising a panel of biospecific capture reagents, each of which specifically binds a biomarker, such that the panel binds CA125, HE4, transferrin, and ApoA1.
34 . The composition of claim 33 , wherein the biospecific capture reagent is an antibody.
35 . The composition of claim 33 , wherein each biospecific capture reagent is bound to a solid support.
36 . (canceled)
37 . A kit comprising the composition of claim 33 , bound to
a solid support; and
instructions for using the composition in the method of claim 1 .
38 - 68 . (canceled)
69 . The composition of claim 35 , wherein the solid support is selected from the group consisting of a bead, plate, membrane, array, or chip.