Vermillion Announces Positive Top-Line Results from the OVA500 Multi-Center Study

Vermillion, Inc. has 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%

Performance in the Pre-menopausal Population
• Sensitivity was reported at 94%

Performance for Early-Stage Ovarian Cancer (I and II)
• Sensitivity was reported at 91%

OVA1 as a Risk Stratification Test (OVA1 score versus cutoff, independent of physician assessment)

• 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%

"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 pre-menopausal 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."

"OVA1 sensitivity and negative predictive value in the OVA500 study met or exceeded the levels reported in the pivotal trial, and confirmed the ability of OVA1 to detect a broad range of ovarian cancer subtypes," said Page.

"Detection of a broad range of cancer subtypes is essential in triage, since it directly increases overall sensitivity and decreases the likelihood of finding a malignancy in patients with a low-risk assessment."

Further details from the study have been submitted for peer-reviewed publication and presentation. Vermillion plans to utilize important findings like these as a tool to continue driving adoption and reimbursement of OVA1.

This latest work brings the total number of prospectively enrolled patients in OVA1 clinical studies to more than 1,000, with a total of 259 malignancies.

Combined, the studies included 84 early-stage ovarian malignancies of which OVA1 correctly identified 78, for a combined risk stratification (stand-alone) sensitivity of approximately 93%.

This key statistic confirms the unrivaled sensitivity of OVA1 for early-stage adnexal malignancies in the critical population of pre-menopausal women, which may aid in pre-surgical detection, referral and prevention of second surgeries.

"These new results point to the possibility of a standardized triage protocol using OVA1, with high sensitivity for all ovarian malignancies including the most curable early-stage cases and a broad range of subtypes," noted Dr. Bristow. "We are especially excited that the sensitive detection of ovarian cancer was paired with the classification of most benign masses as low-risk, and greater than 95% confidence that a negative test will result in a benign pathology finding. Thanks to diagnostic advances like OVA1, there is real hope that the majority of women with ovarian cancer will undergo surgery by a qualified gynecologic oncologist, which is one of the most powerful determinants of survival."

Dr. Bristow is an internationally recognized expert in the surgical management of advanced gynecologic cancer including ovarian, fallopian tube, primary peritoneal, and endometrial cancers. He is the author of four books on ovarian cancer and has published extensively in the field of ovarian cancer research.

He is also an experienced minimally invasive surgeon with special expertise in robotic hysterectomy and surgical staging for endometrial cancer and cervical cancer, and was recently named as one the Best Doctors in America for gynecologic cancers by Best Doctors, Inc.