OVA1 test for ovarian cancer risk is 510(k) approved in USA- Vermillion Inc.

Vermillion, Inc., a bio-analytical solutions company focused on gynecologic disease, announced the receipt of 510(k) marketing clearance from the 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.