According to data presented this week at the European Society of Gynecological Oncology meeting in Milan, Vermillion's OVA1 ovarian cancer diagnostic achieved 98.1 percent sensitivity when used in conjunction with imaging.
Presented by Fred Ueland, associate professor of gynecological oncology at the University of Kentucky's Markey Cancer Center and principal investigator of the multi-center OVA1 clinical trial, the research also showed that OVA1 in combination with imaging demonstrated a negative predictive value of 96.3 percent.
In previous studies, OVA1 without imaging demonstrated 94 percent sensitivity when used as part of the American College of Obstetricians and Gynecologists' referral guidelines, as well as 98 percent sensitivity in early-stage epithelial ovarian cancer and 93 percent in premenopausal early-stage cancers (PM 05/27/2011).
The presentation comes one week after the US Food & Drug Administration granted 510(k) clearance for Fujirebio Diagnostics' Risk of Ovarian Malignancy Algorithm, or ROMA, test for ovarian cancer, a potential competitor to OVA1. In a study of 472 women, the ROMA test demonstrated sensitivity of 93.8 percent, but significantly higher specificity than OVA1 (PM 09/09/2011).