NEW YORK (GenomeWeb News) – Vermillion said today that it has filed for clearance from the US Food and Drug Administration for its OVA1 Ovarian Tumor Triage Test.
The OVA1 test was developed as part of an alliance between Vermillion and Quest Diagnostics.
The Fremont, Calif.-based molecular diagnostics firm said in March that the OVA1 test had met its primary endpoints in a clinical study, and the company expected to file for FDA clearance during the first half of 2008. The test is designed to stratify women with pelvic masses into high-risk and low-risk categories to help determine if they should be referred to a specialist prior to surgery.
Vermillion also is working with Quest on a lab test for peripheral artery disease that will incorporate its protein biomarkers, and which it hopes to commercialize this year.
Shares of Vermillion were up 10.7 percent at $2.28 in early Wednesday trade on the Nasdaq.