Vermillion gets FDA clearance on new ovarian cancer test
March 21, 2016 – AUSTIN. Vermillion, Inc., a bio-analytical solutions company focused on gynecologic disease, announced today the receipt of 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for the successor to Vermillion’s OVA1® test for determining ovarian cancer risk in conjunction with independent clinical and imaging assessment prior to planned surgery for a women with a pelvic mass. The Second Generation OVA1 test, previously referred to as “OVA2”, has been trademarked “Overa®.”
Overa replaces two of the five OVA1 biomarkers with HE4 and FSH in order to improve specificity and reduce the need for physicians to determine menopausal status when interpreting the test. The test is run on a single Roche Cobas 6000 platform, and like OVA1, stratifies patients into low- or high-risk of malignancy on a scale of zero to ten. Whereas other ovarian cancer tests such CA 125, ROMA and OVA1 require patient reported or physician determination of menopausal status, Overa uses a single cutoff of 5, irrespective of menopause. As a result, there is lower possibility of error or confusion, reducing physician work, and simplifying interpretation and patient counseling about the result. Now physicians can offer women even greater peace of mind with the improved specificity and simplified interpretation made possible by Overa.
“Many women still do not receive the proper initial treatment for ovarian cancer,” stated Dr. Robert Coleman, Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center. Dr. Coleman, the lead author of the soon to be published Overa clinical validation study, added, “Overa is specifically designed to help us know which patients are low risk for malignancy and to better identify patients who are at high risk for having a malignancy and, therefore, would benefit from care with a Gynecologic Oncologist.”
Vermillion’s chief medical officer, Dr. Judy Wolf, added, “Overa addresses a critical need for a ‘liquid biopsy’ test to aid in the pre-surgical detection of ovarian cancer across all stages, all ages and histological subtypes. Overa’s improved performance, coupled with our upcoming publications on clinical validation, should position Vermillion to offer early access programs with major healthcare systems. We are working to develop carepath protocols and effective local guidelines that will continue to advance our campaign to accurately identify more women with ovarian cancer.”
“The FDA clearance of Overa represents a major achievement in Vermillion’s mission to provide a vastly improved pre-surgical assessment of the likelihood of malignancy for ovarian cancer,” said Valerie Palmieri, President and CEO of Vermillion. “As the first in its class to receive a second-generation FDA 510(k) clearance, Overa’s proven diagnostic technology running on Roche Cobas 6000, lays a solid foundation for worldwide product and portfolio development to enable more women to benefit from our technology,” Ms. Palmieri added.
Vermillion will report its fourth quarter and full year 2015 financial results on Thursday, March 24, 2016, rather than on Wednesday, March 30, 2016, as previously announced. There will be an investor conference call and webcast at 8:30am Eastern on March 24, 2016 to discuss such financial results.
SOURCE Vermillion, Inc.