AUSTIN, Texas, July 30, 2012 /PRNewswire/ -- Vermillion, Inc. (NASDAQ: VRML ), a leading molecular diagnostics company, today announced positive results from a new prospective, multi-center clinical study of its ovarian cancer diagnostic OVA1®. The study, referred to as OVA500, was led by Dr. Robert E. Bristow, director of Gynecologic Oncology Services at UC Irvine Healthcare in Orange, CA, and deputy editor of the journal Gynecologic Oncology.
OVA1 is a blood test for pre-surgical assessment of ovarian tumors for malignancy using a unique multi-biomarker approach. As the first protein-based, in vitro diagnostic multivariate index assay cleared by the U.S. Food and Drug Administration, OVA1 represents a new class of software-based diagnostics.
The OVA500 study confirms and extends the pioneering work of Dr. Fred Ueland published last year. It was a prospective, multi-institutional, blinded study with a new cohort of 494 patients representing the intended use population for OVA1: female patients who were scheduled to undergo surgery for an adnexal mass, enrolled from non gynecologic oncology practices via 27 study coordination centers.
All adnexal tumor types were included in the statistical analysis of test performance. The primary objective was to assess the performance of OVA1 in the intended use population with a focus on two particularly challenging subgroups: women with early-stage ovarian cancer, where approximately half of patients have a normal CA125 level, and pre-menopausal women, where the incidence of ovarian cancer is low and incidence of benign cysts is high.Top-line data from the study are as follows: Overall Performance of OVA1
- Negative predictive value was reported at 98%
- Sensitivity was reported at 96%
- Specificity was reported at 51%
- Sensitivity was reported at 94%
- Sensitivity was reported at 91%
- Sensitivity was reported at 92% overall:
- 91% for early-stage disease
- 94% for pre-menopausal patients
- 91% for stage I and II in pre-menopausal women with a specificity of 61%