The Ova1 test is intended to identify women with ovarian tumors that are at high risk of being malignant. Data from a 27-site, 511 subject prospective clinical trial were submitted to the FDA in June 2008 in a 510(k) premarket notification.
Vermillion’s 510(k) premarket notification submission is currently pending before the FDA. It has recently reported preliminary data from its Ova1 prospective clinical trial.
Vasclir is a test designed to aid physicians in identifying those patients who are at high risk of developing peripheral artery disease. Vermillion is developing this test in collaboration with John Cooke at Stanford University.
Gail Page, CEO and president of Vermillion, said: “Quest Diagnostics is a pioneer in developing innovative new diagnostic tests and we are very excited to continue this relationship.”