AUSTIN, Texas, Nov. 18, 2014 /PRNewswire/ -- Vermillion, Inc. (NASDAQ: VRML), a bio-analytical solutions company focused on gynecologic disease, 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 (SMAB) 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, Professor of Pathology, Oncology, Urology and Radiology, Director of Clinical Chemistry Division, Department of Pathology, and the Director, Center for Biomarker Discovery and Translation at the Johns Hopkins University School of Medicine. Dr. Chan is an internationally recognized authority in clinical chemistry, proteomics, immunoassay, and cancer biomarkers.
Dr. Robert E. Bristow, who holds the Philip J. DiSaia Chair in Gynecologic Oncology and is the Director of Gynecologic Oncology, and Vice-Chair for Clinical Affairs and Quality Improvement at the University of California, Irvine. Dr. Bristow is recognized as a pre-eminent academic leader in ovarian cancer surgery, and has authored numerous publications highlighting barriers to optimal care following the initial diagnosis of ovarian cancer. He also led the most recent pivotal trial of OVA1, which resulted in four primary research articles in Gynecologic Oncology and the American Journal of Obstetrics and Gynecology.
Calaneet Balas, CEO of the Ovarian Cancer National Alliance (OCNA), brings a wealth of experience in patient-centered policy development. Ms. Balas has more than 15 years' experience in the areas of development and strategic planning. She previously worked at the Arthritis Foundation serving as the Chief Strategy Officer of the Mid-Atlantic Region and as President/CEO of the Arthritis Foundation's Metro DC Chapter. Ms. Balas holds an MBA from Herriot-Watt University, a M.S. in Human Movement Science Education from the University of Memphis and a B.S. in Exercise Science from Truman State University.
"We know to make significant progress in ovarian cancer diagnostics and gynecologic disease, we must enlist the help of innovators, partners and collaborators who share our passion and urgency for rapid advancement in a field with profound unmet need," said Jim LaFrance, Chairman, President & CEO of Vermillion. "We are very grateful to have such a prestigious group of professionals to form the foundation of Vermillion's Strategic & Medical Advisory Board to tackle these important challenges."
Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in gynecologic disease. The company's lead diagnostic, OVA1®, is a blood test for pre-surgical assessment of ovarian tumors for malignancy, using an innovative algorithmic approach. As the first FDA-cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, OVA1 represents a new class of software-based diagnostics. For additional information, including published clinical trials, visit www.vermillion.com.
This press release contains forward-looking statements, as that term is defined in the Private Litigation Reform Act of 1995, that involve significant risks and uncertainties, including statements regarding Vermillion's strategy, future revenue, expected cash outlay, future test volumes, second-generation biomarker panel, expected regulatory approval and future commercial focus. Words such as "may," "expects," "intends," "anticipates," "believes," "estimates," "plans," "seeks," "could," "should," "continue," "will," "potential," "projects" and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained in this press release are based on Vermillion's expectations as of the date of this press release. A variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. Factors that could cause actual results to materially differ from those projected in such forward-looking statements include but are not limited to: (1) Vermillion's ability to increase the volume of OVA1 sales; (2) Vermillion's ability to market its test through sales channels other than Quest Diagnostics; (3) failures by third-party payers to reimburse OVA1 or changes or variances in reimbursement rates; (4) Vermillion's ability to secure additional capital on acceptable terms to execute its business plan; (5) Vermillion's ability to commercialize OVA1 outside the United States; (6) Vermillion's ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; (7) Vermillion's ability to compete successfully; (8) Vermillion's ability to obtain any regulatory approval for Vermillion's future diagnostic products; Vermillion's suppliers' ability to comply with FDA requirements for production, marketing and post market monitoring of its products; (9) Vermillion's ability to maintain sufficient or acceptable supplies of immunoassay kits from its suppliers; (10) Vermillion's ability to continue to develop, protect and promote its proprietary technologies; and (11) other factors that are described in Vermillion's Form 10-K for the year ended December 31, 2013 and Vermillion's Form 10-Q for the quarter ended September 30, 2014 filed with the Securities and Exchange Commission (the "SEC"). Vermillion expressly disclaims any obligation to update, amend or clarify any forward-looking statements to reflect events, new information or circumstances occurring after the date of this press release, except as required by law.
This release should be read in conjunction with the consolidated financial statements and notes thereto included in Vermillion's most recent reports on Form 10-K and Form 10-Q. Copies are available through the SEC's Electronic Data Gathering Analysis and Retrieval system (EDGAR) at www.sec.gov.
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