NEW YORK (GenomeWeb News) – Vermillion said today that its Ovarian Tumor Triage Test met its primary endpoints in a clinical study, and the firm will file for US Food and Drug Administration clearance of the test during the first half of this year, a company spokesperson told GenomeWeb Daily News.
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.
According to the Fremont, Calif.-based firm, the ovarian biomarker panel ruled out malignancy with approximately 95 percent certainty or negative predictive value. The panel also showed roughly 90 percent sensitivity in detecting malignant ovarian tumors, Vermillion said.
The trial was conducted at 27 clinical sites within the US and included more than 550 patients with confirmed adnexal mass.
Vermillion intends to present further study data at a medical conference following submission of its application to the FDA, the spokesperson said.
The firm is working with Quest Diagnostics on a lab test for peripheral artery disease that will incorporate its protein biomarkers, and which it hopes to commercialize this year. In addition, Vermillion recently licensed a biomarker panel from Stanford University that could be used to assess the risk of PAD.