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Vermillion Announces Positive Top-Line Results from the OVA500 Multi-Center Study Led by UC Irvine
Date:7/30/2012

  • Sensitivity was reported at 94%
  • Performance for Early-Stage Ovarian Cancer (I and II)

    • Sensitivity was reported at 91%

    OVA1 as a Risk Stratification Test (OVA1 score versus cutoff, independent of physician assessment)

    • Sensitivity was reported at 92% overall:
      • 91% for early-stage disease
      • 94% for pre-menopausal patients
      • 91% for stage I and II in pre-menopausal women with a specificity of 61%

    "The data are a significant validation of the clinical trial from 2009, and these exciting new results, along with previous clinical data, support the continued efforts to expand our ovarian cancer franchise and create a new approach to treating this deadly disease," said Gail S. Page, CEO of Vermillion. "Ovarian cancer is an area of medicine where there continues to be a significant need for novel approaches. A key goal of the study was to investigate the challenging pre-menopausal setting, where benign cysts have a high incidence and early-stage cancer often goes undetected. OVA1 showed outstanding performance in this population, which clearly addresses an unmet need for physicians and patients alike."

    "OVA1 sensitivity and negative predictive value in the OVA500 study met or exceeded the levels reported in the pivotal trial, and confirmed the ability of OVA1 to detect a broad range of ovarian cancer subtypes," said Page. "Detection of a broad range of cancer subtypes is essential in triage, since it directly increases overall sensitivity and decreases the likelihood of finding a malignancy in patients with a low-risk assessment."

    Further details from the study have been submitted for peer-reviewed publication and presentation. Vermillion plans to utilize important findings like these as a tool to continue driving adoption and reimbursement of OVA1.

    This latest
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    SOURCE Vermillion, Inc.
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