WASHINGTON, Nov. 12, 2013 /PRNewswire/ -- A new study of OVA1® clinical performance in the presurgical detection of ovarian cancer, entitled "Clinical Performance of a Multivariate Index Assay For Detecting Early-Stage Ovarian Cancer," has been published in The American Journal of Obstetrics & Gynecology.
Led by Dr. Robert E. Bristow (UC Irvine Healthcare) and Dr. Frederick R. Ueland (U. Kentucky), the new analysis focuses on presurgical detection of early-stage ovarian cancer among 1,016 ovarian mass surgery patients in two previous pivotal trials conducted in 2007 and 2012.
The study compared OVA1 performance in early-stage ovarian cancer to commonly used cancer risk assessment protocols: overall clinical assessment, the CA125 biomarker or modified-American College of Obstetricians and Gynecologists (mod-ACOG) guidelines for evaluation of suspicious pelvic masses. 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."
"Early-stage ovarian cancer constitutes an important opportunity to improve survival and care for this most deadly gynecologic cancer," said Dr. Bristow. "However, as evidenced by recent studies, most ovarian cancer patients fail to be referred to the doctors and hospitals best equipped to treat them, resulting in unfortunate consequences."Our new study demonstrates OVA1's ability to detect the majority of all early-stage ovarian cancers prior to surgery and thereby aid in appropriately involving a gynecologic oncologist in their care. Even among premenopausal patients where primary 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.