Predictive markers for ovarian cancer
Inventors
Mansfield, Brian C. • Yip, Ping F. • Amonkar, Suraj • Bertenshaw, Greg P.
Assignees
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Publication Number
US-8664358-B2
Publication Date
2014-03-04
Expiration Date
Abstract
Methods are provided for predicting the presence, subtype and stage of ovarian cancer, as well as for assessing the therapeutic efficacy of a cancer treatment and determining whether a subject potentially is developing cancer. Associated test kits, computer and analytical systems as well as software and diagnostic models are also provided.
Core Innovation
The patent describes biomarker-based predictive and diagnostic approaches for ovarian cancer, including estimating the presence of ovarian cancer, ovarian cancer subtype and stage, and monitoring therapeutic efficacy using longitudinal biomarker profiles. The approaches are based on measuring biomarker levels in a specimen using multianalyte biomarker panel assays.
The described systems and assays use specified panels that include combinations of biomarkers and measurable fragments such as CA-125, CRP, EGF-R, CA-19-9, Apo-AI, Apo-CIII, IL-6, IL-18, MIP-1a, Tenascin C, and Myoglobin, as well as related panels with different biomarker combinations. The patent describes analysis and modeling strategies to support prediction and diagnostic determinations, including knowledge discovery engine (KDE), random forests, classification tree analysis, and ROC analysis.
The patent further provides for reagent sets, test kit and multianalyte panel assay kit formats directed to measuring biomarker levels with stated sensitivity and specificity, including about 85% sensitivity and specificity in a population that is symptomatic for ovarian cancer. It also includes the concept that one or more biomarkers can be replaced with a molecule or a measurable fragment located upstream or downstream of the biomarker in a biological pathway.
Claims Coverage
The provided independent claims cover three main reagent-set configurations for measuring ovarian-cancer biomarkers in a specimen, each with about 85% sensitivity and specificity in a population that is symptomatic for ovarian cancer. Across the independent claims, the inventive coverage focuses on multianalyte biomarker reagent sets defined by specific biomarker compositions, with an additional substitution option using biological pathway upstream/downstream molecules or fragments.
Biomarker reagent set for a defined multianalyte panel
A set of reagents to measure the levels of biomarkers in a specimen, wherein the biomarkers are selected from specified panels including CA-125, CRP, EGF-R, CA-19-9, Apo-AI, Apo-CIII, IL-6, IL-18, MIP-1a, Tenascin C and Myoglobin, and measurable fragments, with the set of reagents having a sensitivity and specificity of about 85% in a population that is symptomatic for ovarian cancer.
Reagent set for measuring three or more ovarian-cancer biomarkers
A set of reagents to measure the levels of three or more biomarkers in a specimen, wherein the biomarkers comprise CA125, CRP and CA-19-9 and their measurable fragments, said set of reagents having a sensitivity and specificity of about 85% in a population that is symptomatic for ovarian cancer.
Reagent set for measuring three or more biomarkers including CA125, CRP and EGF-R
A set of reagents to measure the levels of three or more biomarkers in a specimen, wherein the biomarkers comprise CA125, CRP and EGF-R and their measurable fragments, said set of reagents having a sensitivity and specificity of about 85% in a population that is symptomatic for ovarian cancer.
Overall, the claims define multianalyte biomarker reagent sets for measuring ovarian-cancer biomarker levels in a specimen, restricted to specified biomarker panels and limited by a stated about 85% sensitivity and specificity in symptomatic ovarian-cancer populations. Additional claim refinements described in the provided claim set include binding-molecule embodiments, optional upstream/downstream pathway biomarker substitutions, and packaging into a test kit or multianalyte panel assay kit with written instructions for evaluating biomarker results to predict likelihood of ovarian cancer.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Predicting presence of ovarian cancer and ovarian cancer subtype and stage using biomarker profiles and multianalyte panel assays.
Monitoring therapeutic efficacy using longitudinal biomarker profiles.
Predicting the likelihood of ovarian cancer in a subject using biomarker evaluation and written instructions in a multianalyte panel assay kit and/or test kit, as described in dependent claims.
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