Biomarkers for ovarian cancer
Inventors
Fung, Eric T. • Bast, Robert • Podust, Vladimir • Clarke, Charlotte
Assignees
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Publication Number
US-8221984-B2
Publication Date
2012-07-17
Expiration Date
Abstract
The present invention provides protein-based biomarkers and biomarker combinations that are useful in qualifying ovarian cancer status in a patient. In particular, it has been found that the biomarkers set forth in Table 1 are biomarkers for ovarian cancer. The biomarkers can be detected by SELDI mass spectrometry.
Core Innovation
The invention relates to a method for diagnosing ovarian cancer in a subject by measuring a Small MBL-associated protein C-terminal fragment (sMAP) in a urine sample. The measured sMAP level is correlated with ovarian cancer using a reference subject that does not have ovarian cancer, and an elevated level of sMAP as compared to the reference subject indicates that the subject has ovarian cancer.
The disclosure further frames the approach as qualifying ovarian cancer status using protein-based biomarker panels that include sMAP and additional biomarkers. It describes correlation of biomarker measurements with ovarian cancer statuses using classification algorithm concepts and evaluation metrics such as roc/auc sensitivity specificity for distinguishing disease presence and absence and related statuses.
The document discusses detection and analysis in the context of protein biochips/ProteinChip arrays and SELDI/LDI mass spectrometry as a preferred detection platform, with immunoassay provided as an option. It characterizes biomarkers by forms such as C-terminal fragments, glycosylated forms, and truncations, and relates these measured biomarker features to ovarian cancer status determination and monitoring use cases.
Claims Coverage
The partial content identifies one independent claim. It contains two principal inventive features: measuring sMAP in urine from the subject, and correlating the measurement to ovarian cancer using a reference subject, where an elevated sMAP level indicates ovarian cancer.
Measuring sMAP in urine sample
Measuring in a urine sample from the subject Small MBL-associated protein C-terminal fragment (sMAP).
Correlating sMAP to ovarian cancer using a reference subject
Correlating the measurement with ovarian cancer, wherein an elevated level of sMAP as compared to the level of sMAP from a reference subject that does not have ovarian cancer indicates the subject has ovarian cancer, thereby diagnosing ovarian cancer in the subject.
Across the identified independent claim, ovarian cancer diagnosis is achieved by urine-based measurement of sMAP and correlation of that level to ovarian cancer status using a reference subject without ovarian cancer, where elevation of sMAP indicates ovarian cancer. Dependent claim refinements include specifying mass spectrometry (SELDI-MS) or immunoassay for measuring sMAP and performing the correlating step by executing a software classification algorithm.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Distinguishing disease presence and absence and ovarian cancer status based on protein biomarker combinations/biomarker panels.
Risk and stage-related status qualification using correlated biomarker measurements.
Recurrence/progression monitoring and correlation of post-diagnosis sMAP measurements with disease progression after subject management.
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