WASHINGTON, Nov. 12, 2013 /PRNewswire/ -- A new clinical study published in The American Journal of Obstetrics & Gynecology has reported superior sensitivity of OVA1® for presurgical triage of ovarian cancer in a large intended-use population, compared with commonly used risk assessment methods.
The new study compared OVA1 performance to benchmark triage methods, within a combined cohort of 770 ovarian mass surgery patients (including 164 malignancies) from two independent but related OVA1 pivotal trials conducted in 2007 and 2012. The study also compared the actual rate of patient referral from non-specialist physicians to gynecologic oncologists (GO's) with rates predicted from clinical assessment, OVA1, CA125 or from the modified-American College of Obstetricians and Gynecologists (mod-ACOG) guidelines. Vermillion, Inc. (NASDAQ: VRML), the multivariate diagnostics company which developed and currently markets the test, reported the findings today at the American Association of Gynecologic Laparoscopists "42 nd AAGL Global Congress on Minimally Invasive Gynecology."
Dr. Robert E. Bristow, lead author of the study and director of Gynecologic Oncology Services at UC Irvine Healthcare, commented: "Despite widely endorsed treatment standards published by the National Comprehensive Cancer Network, several studies published earlier this year show that only a minority of ovarian cancer patients actually receive treatment by the doctors and hospitals best equipped to care for them. Our new publication shows that the FDA-cleared OVA1 test achieves significantly higher sensitivity than two commonly used methods. And despite lower specificity, the referral rates predicted by OVA1 were roughly comparable to actual clinical practice."
METHODS AND FINDINGSPhysicians participating 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.