Methods for diagnosing ovarian cancer
Inventors
Fung, Eric Thomas • Yip, Tai-Tung • Podust, Vladimir • Brannstrom, Mats • Sundfeldt, Karin • Kristjansdottir, Bjorg
Assignees
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Publication Number
US-8206934-B2
Publication Date
2012-06-26
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, the biomarkers of this invention are useful to classify a subject sample as ovarian cancer, ovarian cancer of low malignant potential, benign ovarian disease or other malignant condition. The biomarkers can be detected by SELDI mass spectrometry, immunoassay, or other means.
Core Innovation
The invention relates to protein biomarker-based diagnostics for qualifying ovarian cancer status in a subject. The approach includes measuring at least one biomarker in ovarian cyst fluid, serum, plasma, blood, or urine, wherein the biomarker includes Protein C inhibitor fragments, and using the measurement to determine ovarian cancer status. Ovarian cancer status includes the presence or absence of ovarian cancer, including malignant, low malignant potential (LMP)/borderline, benign ovarian disease, and other malignancies as described in the partial content.
The measured biomarker value is compared with a diagnostic amount that distinguishes a positive ovarian cancer status from a negative ovarian cancer status. The comparison is correlated with ovarian cancer status such that ovarian cancer status is determined based on the presence or absence of ovarian cancer. The partial content further describes correlating measurements with ovarian cancer status using cutoff values and classification algorithms.
The invention also describes improved diagnostic performance through biomarker combinations or profiles. Biomarker detection is described as being performed using SELDI mass spectrometry, including protein profiling workflow elements, and also using immunoassays in the partial content. The partial content additionally describes analysis and correlation methods, including software classification algorithms such as CART and ANN, and diagnostic performance metrics such as sensitivity and specificity.
Claims Coverage
The partial content includes two independent method claims. Both independent claims cover essentially the same core inventive framework: measure Protein C inhibitor in defined sample matrices, compare to a diagnostic amount that distinguishes positive versus negative ovarian cancer status, and correlate the comparison to whether ovarian cancer is present or absent.
Qualifying ovarian cancer status using Protein C inhibitor biomarker measurement
A method for qualifying ovarian cancer status in a subject comprising measuring at least one biomarker in ovarian cyst fluid, serum, plasma, blood, or urine from the subject, wherein the at least one biomarker is Protein C inhibitor; comparing the measurement with a diagnostic amount that distinguishes a positive ovarian cancer status from a negative ovarian cancer status; and correlating the comparison with ovarian cancer status, wherein the ovarian cancer status is the presence or absence of ovarian cancer.
Diagnosing ovarian cancer using Protein C inhibitor biomarker measurement
A method for diagnosing ovarian cancer in a subject comprising measuring at least one biomarker in ovarian cyst fluid, serum, plasma, blood, or urine from the subject, wherein the biomarker is Protein C inhibitor; comparing the measurement with a diagnostic amount that distinguishes a positive ovarian cancer status from a negative ovarian cancer status; and correlating the comparison with the presence or absence of ovarian cancer.
Both independent claims center on Protein C inhibitor as the biomarker, use ovarian cyst fluid or other specified bodily fluids as sample types, apply a diagnostic amount to distinguish positive and negative ovarian cancer status, and correlate the comparison to determine presence or absence of ovarian cancer.
Stated Advantages
Provides sensitivity and specificity thresholds for diagnostic performance as described in the partial content.
Improves diagnostic performance using biomarker combinations or profiles as described in the partial content.
Documented Applications
Monitoring the course/progression of disease as described in the partial content.
Assessing therapeutic efficacy as described in the partial content.
Communicating diagnoses as described in the partial content.
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