Biomarker for ovarian cancer CTAP3-related proteins
Inventors
Zhang, Zhen • Chan, Daniel W. • Fung, Eric T. • Wang, Zheng • Zhang, Fujun
Assignees
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Publication Number
US-9816995-B2
Publication Date
2017-11-14
Expiration Date
Abstract
The present invention provides a protein-based biomarker that is useful in qualifying ovarian cancer status in a patient. In particular, the biomarker of this invention is useful to classify a subject sample as ovarian cancer or non-ovarian cancer. The biomarker can be detected by SELDI mass spectrometry.
Core Innovation
The invention relates to CTAP3, a platelet basic protein fragment, and CTAP3-related proteins as upregulated serum biomarkers for ovarian cancer. The disclosed biomarkers are detected in serum/plasma using SELDI and other mass spectrometry and immunoassay approaches.
The invention provides diagnostic and qualification methods that correlate measured CTAP3, alone or in combination with CA125 and other listed biomarkers, with ovarian cancer status. The status correlation includes presence/absence, risk, stage, and progression, and uses ROC curve and AUC performance targets for classification.
The invention also covers biomarker characterization and assay components, including mass-to-charge and spectral peak features and features related to IMAC-Cu binding. Kit components are disclosed, including capture reagents and SELDI probes, along with wash solutions and related elements used in the described assay workflows.
Claims Coverage
The provided material includes one independent claim with two main inventive aspects: a defined ovarian-cancer biomarker panel and an assay format in which the biomarkers are bound to antibodies attached to a substrate. The claim specifies five biomarker members and their antibody/substrate binding arrangement.
Defined ovarian cancer biomarker panel
A composition comprising a panel of biomarkers for the diagnosis of ovarian cancer, wherein the panel of biomarkers consists of ApoA1, Beta-2 microglobulin, transthyretin, transferrin, and CA125.
Antibodies attached to a substrate
The biomarkers are bound to antibodies attached to a substrate.
Across the independent claim, the scope is directed to a diagnostic composition for ovarian cancer using a specified biomarker panel (ApoA1, Beta-2 microglobulin, transthyretin, transferrin, and CA125) in which the biomarkers are bound to antibodies attached to a substrate.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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