Molecular diagnostics company Vermillion Inc. has announced positive results from a new prospective, multicenter 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 presurgical assessment of ovarian tumors for malignancy using a multibiomarker approach. As the first protein-based, in vitro diagnostic multivariate index assay cleared by FDA, OVA1 represents a new class of software-based diagnostics.
The OVA500 study confirms and extends the work of Dr. Fred Ueland published last year. It was a prospective, multiinstitutional, 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 nongynecologic 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 premenopausal 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:
Performance in the premenopausal population:
Performance for Early-Stage Ovarian Cancer (I and II):
OVA1 as a risk stratification test (OVA1 score versus cutoff, independent of physician assessment). Sensitivity was reported at 92% overall:
"The data are a significant validation of the clinical trial from 2009, and these exciting new results, along with previous clinical data, support the continued efforts to expand our ovarian cancer franchise and create a new approach to treating this deadly disease," said Gail S. Page, CEO of Vermillion. "Ovarian cancer is an area of medicine where there continues to be a significant need for novel approaches. A key goal of the study was to investigate the challenging premenopausal setting, where benign cysts have a high incidence and early-stage cancer often goes undetected. OVA1 showed outstanding performance in this population, which clearly addresses an unmet need for physicians and patients alike."
Read the full press release on the Vermillion website.