Vermillion, Inc announces that it has agreed with Quest Diagnostics to extend the Strategic Alliance Agreement between the parties through October, 2009. This extension will enable the companies to continue work on the development and commercialization of two tests, OVA1™ and VASCLIR™.
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 of this year in a 510(k) premarket notification. Vermillion’s 510(k) premarket notification submission is currently pending before the FDA.
To date, Vermillion and the FDA have had several substantive discussions regarding the submission. Vermillion has been encouraged by the constructive nature of these discussions and by the interactive review process. Vermillion believes that it will be able to provide information and data that will respond to the FDA’s questions during this quarter.
Additionally, this week Vermillion presented preliminary data from its OVA1 prospective clinical trial at the International Gynecologic Cancer Society’s 12th Biennial Meeting. The oral presentation, "A Biomarker Panel for Distinguishing Between Malignant and Benign Ovarian Tumors" was co-authored by scientists at Vermillion, Dr. Fred Ueland, Associate Professor of Gynecologic Oncology at the University of Kentucky and Principal Investigator of the OVA1 trial, and Dr Zhen Zhang, Associate Professor of Pathology at Johns Hopkins University School of Medicine.
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 Dr John Cooke at Stanford University. Results from a 540 subject validation study were recently published in the peer-reviewed journal, Vascular Medicine.
"Quest Diagnostics is a pioneer in developing innovative new diagnostic tests and we are very excited to continue this relationship," said Gail S Page, CEO and President of Vermillion.