Predictive biomarkers for ovarian cancer
Inventors
Mansfield, Brian C. • Yip, Ping F. • Amonkar, Suraj • Bertenshaw, Greg P.
Assignees
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Publication Number
US-9846158-B2
Publication Date
2017-12-19
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 invention relates to an ovarian cancer predictive and diagnostic framework that uses multianalyte profiling of biomarkers measured in a patient specimen. The framework selects a biomarker panel and measures biomarker levels in the specimen, preferably from blood serum or plasma, to support prediction regarding ovarian cancer.
The framework predicts the presence of ovarian cancer and assigns an ovarian cancer stage chosen from Stage IA, IB, IC, II, III, or IV tumors. It also supports assessment of therapeutic efficacy by comparing biomarker profiles over time, including longitudinal monitoring across specimens collected before and after or during a treatment course.
The framework further determines whether a subject may be developing cancer, with reported performance targets for sensitivity and specificity. Biomarker-panel concepts enumerate panels containing CA125, Apo A1, HE4, and FSH, with optional inclusion of IL-6, EGFR, CRP, transferrin, transthyretin, and Beta-2 Microglobulin, and the system includes modeling and analysis using a knowledge discovery engine (KDE) and machine learning approaches such as random forests and classification tree analysis.
Claims Coverage
Two independent claims are identified. Each independent claim centers on a predefined multibiomarker panel measured in a specimen, implemented as a set of reagents or a set of antibodies fixed to a microsphere, with the panels enumerated as specific combinations of named biomarkers.
Set of reagents to measure biomarker panels in a specimen
A set of reagents to measure the levels of biomarkers in a specimen, wherein the biomarkers are selected from panels enumerated to include combinations of CA125, Apo A1, HE4, and FSH, with optional inclusion of IL-6, EGFR, CRP, transferrin, transthyretin, and Beta-2 Microglobulin, or measurable fragments thereof.
Microsphere-fixed antibodies to measure biomarker panels in a specimen
A set of antibodies fixed to a microsphere to measure the levels of biomarkers in a specimen, wherein the biomarkers are selected from panels enumerated to include combinations of CA125, Apo A1, HE4, and FSH, with optional inclusion of IL-6, EGFR, CRP, transferrin, transthyretin, and Beta-2 Microglobulin, or measurable fragments thereof.
Overall, the claims define specific multianalyte biomarker panel reagent sets, including microsphere-fixed antibodies, with biomarker content restricted to enumerated combinations built around CA125, Apo A1, HE4, and FSH and optional additional biomarkers.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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