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As announced previously, the OVA1 prospective clinical trial met itsprimary endpoints, indicating that the test is capable of stratifying womenwith pelvic masses into high- and low-risk categories to help determinewhether the patient should be referred to a specialist prior to surgery. Theclinical trial was one of the largest ovarian cancer studies ever conductedand assessed more than 550 women with a confirmed adnexal mass at 27 clinicalsites in the United States. Additionally, the trial was the culmination ofmore than eight independent studies in more than 2500 women.
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"The OVA1 test will help assess the risk of malignancy in the hundreds ofthousands of women who require surgery for ovarian tumors each year. Thisinformation can be used to identify those who might benefit from referral to agynecologic oncologist," said Fred Ueland, M.D., principal investigator of thestudy and Associate Professor of Gynecologic Oncology at the University ofKentucky. "While most tumors are benign, numerous studies have shown thatwomen with ovarian cancer have better overall outcomes when their surgery isperformed by a gynecologic oncologist."
"This is an important milestone for Vermillion and a significant steptoward the commercialization of OVA1. We are pleased with the results of thetrial and look forward to discussing the significance of our data and ourcommercialization strategy in an upcoming investor roundtable, planned forJuly," said Gail Page, President and CEO of Vermillion. "We also look forwardto receiving regulatory clearance from the FDA and making OVA1 available tothe hundreds of thousands of women who could benefit considerably from thetest."
Vermillion will host a roundtable teleconference to address the need forOVA1 on Tuesday, July 15. Fred Ueland, M.D., principal investigator of theOVA1 clinical study, will serve as the keynote speaker. Conference calldetails, including dial-in information and timing, are forthcoming.
About Vermillion's Ovarian Cancer Diagnostic Program
In addition to developing a diagnostic test designed to distinguishbetween benign and malignant pelvic masses, Vermillion has a broad program ofovarian cancer diagnostic tests in development. Studies are underway tovalidate diagnostic tests developed to detect early-stage ovarian cancer,predict prognosis and recurrence, and identify women considered at high-riskfor the disease.
Vermillion's comprehensive diagnostic development program is beingconducted with several leading collaborators at The Johns Hopkins School ofMedicine, The University of Texas M.D. Anderson Cancer Center, Rigshospitalet(Copenhagen), and the University of Kentucky.
The Company's OVA1 test is part of a strategic alliance with QuestDiagnostics to jointly develop and commercialize diagnostic tests.
About Vermillion
Vermillion, Inc. is dedicated to the discovery, development andcommercialization of novel high-value diagnostic tests that help physiciansdiagnose, treat and improve outcomes for patients. Vermillion, along with itsprestigious scientific collaborators, has diagnostic programs in oncology,hematology, cardiology and women's health. Vermillion is based in Fremont,California. Additional information about Vermillion can be found on the Web athttp://www.vermillion.com.
Forward Looking Statements
This news release contains forward-looking statements that involvesignificant risks and uncertainties, including statements regardingVermillion's plans, objectives, expectations and intentions. Theseforward-looking statements are based
