Biomarker Panel for Ovarian Cancer Risk Assessment
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Solution Overview
Problem
Current methods for identifying ovarian cancer in adnexal masses are inadequate, as they often fail to accurately differentiate between benign and malignant masses, leading to unnecessary surgical interventions and delayed diagnosis.
Innovation Solution
A method using a panel of biomarkers, including CA125, HE4, beta-2 microglobulin, apolipoprotein A-1, transferrin, transthyretin, and follicle stimulating hormone, to assess ovarian cancer risk in subjects with adnexal masses, allowing for conservative management of benign masses and targeted intervention for those with indeterminate or high risk of malignancy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If current methods are used to identify ovarian cancer in adnexal masses, then the diagnosis process is simple, but the accuracy of differentiating benign from malignant masses is insufficient
Solution Approach 1:
The patent combines multiple biomarkers (CA125, HE4, beta-2 microglobulin, apolipoprotein A-1, transferrin, transthyretin, and FSH) into a unified panel to assess ovarian cancer risk. This merging of multiple diagnostic indicators into a single comprehensive assessment system resolves the contradiction by achieving high differentiation accuracy through biomarker combinations while maintaining practical clinical usability through an integrated scoring system.
2Reliability
If surgical intervention is performed on all adnexal masses to ensure cancer detection, then the detection of ovarian cancer is maximized, but unnecessary surgeries increase
Solution Approach 1:
The patent implements preliminary risk assessment using the biomarker panel before surgical intervention. By performing this preliminary evaluation, the system identifies patients who truly need surgery versus those who can undergo conservative management, thereby preventing unnecessary surgical interventions while maintaining high reliability in detecting actual ovarian cancer cases.
Solution Approach 2:
The biomarker panel serves as an intermediary between adnexal mass detection and surgical intervention. This intermediary assessment layer provides objective risk stratification, allowing clinicians to make informed decisions about which patients require surgery and which can be managed conservatively, thus reducing harmful unnecessary surgeries while maintaining cancer detection reliability.
3Measurement precision
If a single biomarker is used for assessment, then the test is simple and quick, but the accuracy of risk assessment is insufficient
Solution Approach 1:
The patent uses a composite biomarker panel where multiple different biomarkers work together synergistically to assess ovarian cancer risk. Each biomarker contributes unique information about different aspects of ovarian pathology, and their combined assessment provides superior accuracy compared to any single biomarker, while the integrated scoring system manages the complexity of measuring multiple markers.
Data Source
AI summary
The present invention provides methods for the assessment of an adnexal mass predetermined to be benign or asymptomatic (e.g., asymptomatic or benign adnexal mass) in a variety of subjects (e.g., pre- and post-menopausal women). In particular, the present invention provides methods for determining the malignancy risk of ovarian tumors in selected subjects (e.g., benign or indeterminate risk).