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American Journal of Obstetrics & Gynecology Publishes New Clinical Study Showing Positive Performance of Vermillion's OVA1 Test in Presurgical Detection of Early-Stage Ovarian Cancer
Date:11/12/2013

ovarian cancer prevalence was only 15%, clinical assessment with OVA1 detected early-stage ovarian cancer with nearly 90% sensitivity. This is a very encouraging development for diagnosis and treatment of ovarian cancer."

METHODS AND FINDINGS

As a benchmark of usual care, physicians were required to predict whether ovarian masses were malignant or benign following overall clinical assessment, which included physical examination and imaging, family history, and laboratory tests (including CA125, if used). Overall success of clinical assessment in predicting an early-stage malignancy (confirmed by pathology) was 68.6% (59 of 86 malignancies), while 31.4% were mistakenly predicted to be benign. For stage I malignancies the percent detected fell to 63.9% (39/61), with 36.1% mistakenly predicted to be benign. Adding OVA1 to clinical assessment successfully identified 95.3% of early-stage cancers (82/86) and 93.4% of stage I malignancies (57/61) – a reduction in cancers missed of 85% (early-stage) and 82% (stage I), respectively over clinical assessment alone.

Among three risk-stratification methods compared directly for early-stage cancer detection, OVA1 showed the highest sensitivity (91.9%, or 79/86). OVA1 sensitivity was significantly higher than either benchmark method: sensitivity of the mod-ACOG guidelines was 76.7% (66/86) while CA125 sensitivity was 62.8% (54/86). The number of malignancies incorrectly stratified as low risk by CA125, mod-ACOG and OVA1 was 37.2%, 23.3% and 8.1%, respectively.

Early-stage cancer detection by OVA1 was 85.7% among premenopausal patients and 94.8% among postmenopausal patients. In contrast, CA125 alone correctly classified just 35.7% in premenopausal patients and 75.9% in postmenopausal patients. Used as intended together with clinical assessment, OVA1 sensitivity was 89.3% and 98.3% for pre- and post-menopausal early-stage cancer detection.

Dr. Donald Munroe, Ver
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SOURCE Vermillion, Inc.
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