Abstract 6P
Background
Ovarian ranks seventh in women's cancers and eighth in female cancer-related deaths. Despite its low incidence, its impact is substantial due to late detection and limited treatment options. Named the 'silent killer' for its vague symptoms, it often leads to delayed diagnosis and metastasis. Hence, early detection remains challenging. Thus, we present Venient Sx Ovarian Basic (Kience Inc., Wilmington, US) a novel non-invasive test for ovarian cancer early detection. This diagnostic tool aims to accurately detect ovarian cancer, even in early stages, before symptoms appear and when treatment is most likely to succeed.
Methods
Venient Sx Ovarian Basic, designed specifically around serum biomarkers for ovarian cancer screening. It primarily relies on the tumor markers CA 19.9, CEA, and the ROMA score, which incorporates key factors such as age, menopausal status, and serum levels of CA 125 and HE4, to generate the likelihood of ovarian cancer, distinguishing between mucinous and serous epithelial ovarian cancer. To assess the estimated accuracy of our test, we conducted an extensive literature review of diagnostic accuracy studies about constituent algorithms, calculations, and combinations of analytes included within it. Parallel approximations were conducted to optimize overall sensitivity (Se), followed by serial approximations to enhance specificity (Sp), a process performed by our own machine learning (ML) algorithm.
Results
We obtained a final sample size (n) of 9,324 individuals and achieved a Se of 0.97 and a Sp of 0.93. Subsequently, we conducted an approximation of the area under the receiver operating characteristic (AUROC) curve, as well as estimations for the positive predictive value (PPV) and the negative predictive value (NPV) based on these results, yielding values of 0.92, 0.93, and 0.97, respectively.
Conclusions
This data suggests that the innovative non-invasive blood-based biomarker algorithm, Venient Sx Ovarian Basic, holds promise in providing timely ovarian cancer screening, particularly among individuals aged 40 and above. We are conducting an extensive parallel study with additional ovarian analytes to increase the Se of the test and offer the physicians a tool with minimum false negatives (FN).
Legal entity responsible for the study
Kience Inc..
Funding
Kience Inc..
Disclosure
S.J. Calleja Freixes: Financial Interests, Personal and Institutional, Ownership Interest: Kience Inc.. All other authors have declared no conflicts of interest.