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November 28, 2012
10:45 EDTVRMLGO publishes new study showing positive performance of Vermillion test
Gynecologic Oncology has published the second prospective clinical study of OVA1 which demonstrated the positive performance of the multi-biomarker test in the triage of early-stage ovarian cancer. Vermillion, the molecular diagnostics company which developed and currently markets the test, had reported positive top-line results of the study in July. Referred to as "OVA500," the study confirms and extends the findings of the first OVA1 pivotal study published last year in Obstetrics & Gynecology by Dr. Fred Ueland of the University of Kentucky. The multi-center study investigated OVA1 performance in the pre-surgical detection of malignancy among 494 women prospectively enrolled from non-gynecologic oncology practices. Sensitivity across all types of ovarian cancers was 96% when OVA1 was added to routine clinical assessment, and this result was nearly identical to the first pivotal study. Importantly, within the test group OVA1 identified 83% of cancers missed by clinical assessment and 71% of cancers missed by CA125.
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November 18, 2014
17:48 EDTVRMLVermillion outlines strategic mission, forms new medical advisory board
Vermillion recently outlined its expanded strategy for driving improvements in the personalized management of gynecologic health and becoming the leading diagnostic innovator in gynecologic informatics. In support of this mission, the company is naming three charter members of its Strategic & Medical Advisory Board. To date, Vermillion has focused on one "leg" of the clinical decision tree that begins with hundreds of thousands of women seeking treatment for non-specific gynecologic symptoms including pain, infertility or irregular menstrual cycles. Vermillion hopes to aid clinicians in the triage of these women into effective and cost efficient treatment pathways that address both malignant and benign gynecologic disease. "Just as Vermillion succeeded in identifying the OVA1 algorithm which pre-operatively predicts ovarian cancer status, similar tools can be used to predict and diagnose the other conditions found in what we call the 'confusion matrix.' Early detection and diagnosis translates into quality of care, and aids in cost-effective, targeted, management of patients," said Dr. Judith Wolf, Vermillion's Chief Medical Officer. Ova1 uses protein biomarkers and a multivariate algorithm. This tool set will improve with the planned launch of the second generation OVA1 product (OVA2), targeted for the second half of 2015. The company also plans to develop and bring online an increasing array of tools beyond biomarkers and pure diagnostic measurement. "We now view informatics and care pathways, not simply biomarkers, as part of the formula for achieving our goal of optimizing care for women who are facing serious malignant and benign gynecologic conditions. To that end, we plan to expand our predictive tools to include other modalities, clinical risk factors, and patient informatics in our calculus. These proprietary predictive methods will use newly discovered correlations and algorithms as exemplified in the American Journal of Obstetrics & Gynecology article on OVA1 and imaging published earlier this year, to better diagnose and therefore effectively treat women," said Dr. Donald Munroe, Vermillion's Chief Scientific Officer. In support of these goals, the company has formed a Strategic & Medical Advisory Board that will be comprised of leading experts in a diverse range of subjects including gynecologic oncology, clinical chemistry, data science, reimbursement & medical policy, and patient advocacy. The SMAB will be co-led by Vermillion's Dr. Wolf and Dr. Munroe. Its charter members are: Dr. Daniel Chan, Dr. Robert E. Bristow, and Calaneet Balas.

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