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Vermillion's OVA1 Receives New Statement by Society of Gynecologic Oncology
Date:6/11/2013

AUSTIN, Texas, June 11, 2013 /PRNewswire/ -- Vermillion, Inc.'s (NASDAQ: VRML), a multivariate diagnostics company focused on gynecologic cancers and women's health, OVA1® has received a new statement on clinical validation and medical use issued by the Society of Gynecologic Oncology (SGO).

Citing peer-reviewed publications from two pivotal clinical studies of OVA1® versus standard of care, the statement also referred to OVA1 use within the context of the American Congress of Obstetricians and Gynecologists' (ACOG) 2011 Committee Opinion, "The Role of the Obstetrician-Gynecologist in the Early Detection of Epithelial Ovarian Cancer." This guideline, updated from a previous version issued in 2002, covers the management of adnexal masses, including serum markers for ovarian cancer detection.

SGO stated: "…The test may be useful in identifying women who should be referred to a gynecologic oncologist. Recent data have suggested that the OVA1 test along with physician clinical assessment may improve detection rates of malignancies among women with pelvic masses planning surgery." The complete statement on OVA1 clinical validation and medical use is available on SGO's website here.

This second SGO statement on OVA1 since its FDA clearance in 2009 represents another significant step toward acceptance of OVA1 as the standard of care for pre-surgically evaluating the risk of ovarian cancer in women with adnexal masses. 

The new statement does two things:

  • Refers to publications of OVA1's two pivotal clinical studies, comprised of the original FDA validation study published in June 2011 and the OVA500 "intended use" study published in 2013. Together, this offers an extensive, peer-review
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SOURCE Vermillion, Inc.
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