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Vermillion files 510(k) pre-market application for ovarian tumour test
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Vermillion
: 26 June, 2008 (Company News) |
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Vermillion has submitted a 510(k) pre-market notification application to the US Food and Drug Administration (FDA) that requests regulatory clearance of its Ovarian Tumor Triage Test known as OVA1. |
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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 one of the largest ovarian cancer studies ever conducted and assessed more than 550 women with a confirmed adnexal mass at 27 clinical sites in the USA. Additionally, the trial was the culmination of more than eight independent studies in more than 2500 women.
'The OVA1 test will help assess the risk of malignancy in the hundreds of thousands of women who require surgery for ovarian tumours each year. This information can be used to identify those who might benefit from referral to a gynaecologic oncologist,' said Fred Ueland, MD, principal investigator of the study and associate professor of Gynecologic Oncology at the University of Kentucky. 'While most tumours are benign, numerous studies have shown that women with ovarian cancer have better overall outcomes when their surgery is performed by a gynaecologic oncologist.'
'This is an important milestone for Vermillion and a significant step toward the commercialisation of OVA1. We are pleased with the results of the trial and look forward to discussing the significance of our data and our commercialisation strategy in an upcoming investor roundtable, planned for July,' said Gail Page, president and chief executive officer of Vermillion. 'We also look forward to receiving regulatory clearance from the FDA and making OVA1 available to the hundreds of thousands of women who could benefit considerably from the test.'
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