Biomarkers 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-11255857-B2
Publication Date
2022-02-22
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 provides CTAP3 as a CTAP3-derived polypeptide biomarker for ovarian cancer, including a defined CTAP3 fragment derived from precursor PPBP. CTAP3 is described as upregulated in ovarian cancer serum relative to controls, enabling determination of ovarian cancer status.
The document describes diagnostic detection characteristics for CTAP3 using SELDI/TOF-MS, including an IMAC interaction after washing conditions and a mass-to-charge signal characteristic at a specified M/Z value. Performance is described using ROC curve analysis and AUC-based thresholds for classifying ovarian cancer status.
The invention further includes diagnostic algorithms that use CTAP3, including classification of ovarian cancer status as presence versus non-cancer, as well as risk, stage, and progression classifications. The document additionally describes biomarker panel concepts that combine CTAP3 with other biomarkers and bind the biomarkers to capture reagents attached to a substrate, including optional immunoassay detection.
Claims Coverage
The independent claims cover substrate-bound biomarker panels for determining ovarian cancer status, with inventive features centered on specific biomarker sets and capture reagent attachment to a substrate, using either transferrin or transthyretin and, in refinements, antibodies as capture reagents. Across the independent claims, four core biomarker identifiers recur: ApoA1, Beta-2 microglobulin, HE4, and CA125, with transferrin/transthyretin included in additional sets.
Substrate-bound ovarian cancer biomarker panel consisting of ApoA1, Beta-2 microglobulin, HE4, and CA125
A composition comprising a panel of biomarkers for determining ovarian cancer status, wherein the panel of biomarkers consist of Apolipoprotein A1 (ApoA1), Beta-2 microglobulin, Human Epididymis Protein 4 (HE4), and Cancer Antigen 125 (CA125), and wherein the biomarkers are bound to capture reagents attached to a substrate.
Substrate-bound ovarian cancer biomarker panel including ApoA1, Beta-2 microglobulin, HE4, CA125, and transferrin or transthyretin
A panel of biomarkers for determining ovarian cancer status, wherein the panel of biomarkers consist of Apolipoprotein A1 (ApoA1), Beta-2 microglobulin, Human Epididymis Protein 4 (HE4), and Cancer Antigen 125 (CA125), and transferrin or transthyretin, and wherein the biomarkers are bound to capture reagents attached to a substrate.
Substrate-bound ovarian cancer biomarker composition including ApoA1, Beta-2 microglobulin, HE4, CA125, transferrin, and transthyretin
A composition comprising a panel of biomarkers for determining ovarian cancer status, wherein the panel of biomarkers consist of Apolipoprotein A1 (ApoA1), Beta-2 microglobulin, Human Epididymis Protein 4 (HE4), and Cancer Antigen 125 (CA125), transferrin and transthyretin, and wherein the biomarkers are bound to capture reagents attached to a substrate.
Overall, the claim coverage is focused on ovarian-cancer-status determinations using defined biomarker panels (ApoA1, Beta-2 microglobulin, HE4, CA125 with optional inclusion of transferrin or transthyretin) in which the biomarkers are bound to capture reagents attached to a substrate. The document’s refinements further specify that the capture reagents can be antibodies.
Stated Advantages
Enables determining ovarian cancer status using a biomarker panel with ROC/AUC-based classification performance as described.
Supports classification beyond simple presence/absence by describing risk, stage, and progression determinations.
Documented Applications
Diagnostic use for determining ovarian cancer status, including presence versus non-cancer and classification for risk, stage, and progression as described.
Monitoring treatment efficacy/therapeutic response as described.
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