Vermillion Files Pre-Marketing Application to FDA for Ovarian Tumor Test
Vermillion has submitted a 510(k) pre-market notification application to the FDA requesting regulatory clearance of its ovarian tumor triage test known as OVA1.
As announced previously, the OVA1 prospective clinical trial met its primary endpoints, indicating that the test is capable of stratifying women with pelvic masses into high- and low-risk categories to help determine whether the patient should be referred to a specialist prior to surgery.
The clinical trial was said to be the largest ovarian cancer studies ever conducted and assessed more than 550 women with a confirmed adnexal mass at 27 clinical sites in the US. Additionally, the trial was the culmination of more than eight independent studies in more than 2,500 women.
Fred Ueland, principal investigator of the study, said: “The OVA1 test will help assess the risk of malignancy in the hundreds of thousands of women who require surgery for ovarian tumors each year. This information can be used to identify those who might benefit from referral to a gynecologic oncologist.”