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American Journal of Obstetrics & Gynecology Publishes New Clinical Study Showing Positive Performance of Vermillion's Ovarian Cancer Test, OVA1
Date:11/12/2013

in the study were required to predict whether ovarian masses were malignant or benign following clinical assessment. The clinical assessment stipulated physical examination and imaging, family history, and laboratory tests (including CA125, if used). OVA1 performance as a risk stratification test was compared with clinical assessment, Predicted and actual referral rates were analyzed and predictions were compared with final pathology results.

Clinical assessment correctly predicted 120 of 164 malignancies (73.2%), while 44 were mistakenly predicted to be benign (26.8%). Among three risk-stratification methods compared, OVA1 showed the highest sensitivity (148/164, or 90.2%). OVA1 sensitivity was significantly higher than either benchmark method: sensitivity of the mod-ACOG guidelines was 130/164 (79.3%) while CA125 sensitivity was 112/164 (68.4%). The number of malignancies incorrectly stratified as low risk by CA125, mod-ACOG and OVA1 was 52 (31.6%), 34 (20.7%) and 16 (9.8%), respectively.

OVA1 performance predicted an overall referral rate of 55.7%, slightly lower than the actual referral rate of 60.0% observed across all patients in the study. Despite the other risk stratification methods predicting lower overall referral rates, approximately 48-52% of patients rated as low risk were nevertheless referred in actuality. Reasons for these unexpected referrals were not evident.

"This study, focused on intended-use patients enrolled through 44 sites nationwide, found that OVA1 sensitivity was statistically superior to CA125 or the other risk stratification protocols examined," stated Dr. Donald Munroe, Vermillion's chief scientific officer and SVP of business development. "While high sensitivity and negative predictive value are diagnostic imperatives for presurgical ovarian cancer triage, the work also shed light on patient referral patterns with or without OVA1. Notably, the predicted OVA1 referral rate was compar
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SOURCE Vermillion, Inc.
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