NEW YORK (GenomeWeb News) – Vermillion today said that Medicare will cover its OVA1 test for help in determining the likelihood that an ovarian mass is benign or malignant.
Highmark Medicare Services is the CMS contractor that will process Medicare claims for OVA1.
The OVA1 test was cleared for marketing in September 2009 by the US Food and Drug Administration to market its OVA1 test for helping physicians determine if a woman is at risk for a malignant pelvic mass prior to surgery. The in vitro diagnostic multivariate test utilizes five biomarkers and was developed in collaboration with Quest Diagnostics, which has exclusive rights to offer the test to the clinical lab market in the US for three years. It is the first proteomic-based IVDMIA to gain FDA clearance.
The firms launched the test earlier this week.
"This decision by Highmark Medicare Services reaffirms our belief that OVA1 can provide meaningful clinical information to assist physicians in identifying women with a high likelihood of having malignancy prior to planned surgery," Vermillion CEO Gail Page said in a statement.