(assay testing - repost) Ovarian malignancy risk stratification of the adnexal mass using a multivariate index assay

Abstract

Highlights

► The multivariate index assay (MVA) was evaluated in an intended-use population of non-gynecologic oncology practices.
► The MVA demonstrated high sensitivity and NPV for ovarian malignancy.
► The MVA correctly identified 83.3% malignancies missed by clinical impression and 70.8% cases missed by CA125-II.

• ^a University of California, Irvine-Medical Center, Orange, CA, USA
• ^b Applied Clinical Intelligence, Bala Cynwyd, PA, USA
• ^c The Johns Hopkins Medical Institutions, Baltimore, MD, USA
• ^d Vermillion, Inc., Mountain View, CA, USA
• ^e Vermillion, Inc., Austin, TX, USA

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Objective

To validate the effectiveness of a multivariate index assay in identifying ovarian malignancy compared to clinical assessment and CA125-II, among women undergoing surgery for an adnexal mass after enrollment by non-gynecologic oncology providers.

Methods

A prospective, multi-institutional trial enrolled female patients scheduled to undergo surgery for an adnexal mass from 27 non-gynecologic oncology practices. Pre-operative serum samples and physician assessment of ovarian cancer risk were correlated with final surgical pathology.

Results

A total of 494 subjects were evaluable for multivariate index assay, CA125-II, and clinical impression. Overall, 92 patients (18.6%) had a pelvic malignancy. Primary ovarian cancer was diagnosed in 65 patients (13.2%), with 43.1% having FIGO stage I disease. For all ovarian malignancies, the sensitivity of the multivariate index assay was 95.7% (95%CI = 89.3–98.3) when combined with clinical impression. The multivariate index assay correctly predicted ovarian malignancy in 91.4% (95%CI = 77.6–97.0) of cases of early-stage disease, compared to 65.7% (95%CI = 49.2–79.2) for CA125-II. The multivariate index assay correctly identified 83.3% malignancies missed by clinical impression and 70.8% cases missed by CA125-II. Multivariate index assay was superior in predicting the absence of an ovarian malignancy, with a negative predictive value of 98.1% (95%CI = 95.2–99.2). Both clinical impression and CA125-II were more accurate at identifying benign disease. The multivariate index assay correctly predicted benign pathology in 204 patients (50.7%, 95%CI = 45.9–55.6) when combined with clinical impression.

Conclusion

The multivariate index assay demonstrated higher sensitivity and negative predictive value for ovarian malignancy compared to clinical impression and CA125-II in an intended-use population of non-gynecologic oncology practices.

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Graphical abstract

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Highlights

► The multivariate index assay (MVA) was evaluated in an intended-use population of non-gynecologic oncology practices. ► The MVA demonstrated high sensitivity and NPV for ovarian malignancy. ► The MVA correctly identified 83.3% malignancies missed by clinical impression and 70.8% cases missed by CA125-II.