Moffitt Cancer Center and Vermillion Collaborate to Model Improvements in Ovarian Cancer Care Quality, Patient Outcomes and Cost
AUSTIN, Texas, May 8, 2014 /PRNewswire/ -- A new research collaboration anchored by Moffitt Cancer Center in Tampa, Fla., was announced today in conjunction with World Ovarian Cancer Day. The purpose of the study is to produce clinical and economic data to support a new value-based practice model that may improve survival, quality of life and cost-effectiveness of care for patients with ovarian cancer. The study will be led by Johnathan M. Lancaster, M.D., Ph.D., a gynecologic oncologist, expert in personalized medicine and president of the Moffitt Medical Group, and funded through an unrestricted grant from Austin-based Vermillion, Inc. It will feature two phases, the first phase will be retrospective, and will benchmark the care standards and variances provided to patients with ovarian, fallopian tube and/or primary peritoneal cancer. The second phase will model improvements in care quality and cost that may be afforded by creating a standardized triage algorithm employing different FDA-cleared or prototype multi-marker blood tests, along with established clinical diagnostic or prognostic factors such as pelvic exams and ultrasound imaging.
"It is imperative that we rapidly develop high-quality, cost-effective strategies for the diagnosis and treatment of ovarian cancer," said Dr. Lancaster. "Multiple studies have shown that patients with ovarian cancer who are treated from the beginning by a board-certified gynecologic oncologist have a better chance of beating the disease. Yet in the U.S., fewer than half of the patients with the disease receive care from a gynecologic oncologist. This likely contributes to the high death rate from the disease, and is simply unfair to patients. We have a duty to develop clinical management strategies that will change this pattern – to improve survival rates, quality of life, and the cost-effectiveness of care in our communities."
Nearly 22,000 women are diagnosed with ovarian cancer in the U.S. annually, and more than 14,000 die each year, making it the deadliest of all gynecologic cancers.1 Treatment advances during the last three decades have modestly improved the average length of survival following a diagnosis of ovarian cancer. Women diagnosed with ovarian cancer in 1975 had a five-year survival rate of 33.6 percent. Today, the rate is still only 44 percent.2
"Today, on World Ovarian Cancer Day, we honor the thousands of women who have lost their lives to ovarian cancer, as well as the women, their families and care teams who are fighting this disease," said James LaFrance, chairman, president and chief executive officer of Vermillion. "Reducing the burden of ovarian cancer is central to our mission and to the health of women in the U.S. With the expertise of Dr. Lancaster and the Moffitt team, we believe this effort will facilitate an important dialogue and establish a path to improving ovarian cancer care and outcomes."
The study will measure the baseline triage effectiveness, treatment standards, early outcomes and cost of care for patients diagnosed with an adnexal malignancy. From this baseline, potential improvement in care and cost effectiveness will be calculated for different triage protocols, including molecular or proteomic biomarkers, such as the OVA1® blood test. OVA1 is an FDA-cleared, highly sensitive blood test that offers a way to predict whether a suspicious pelvic mass is malignant or benign, helping triage a woman to a gynecologic oncologist more quickly. OVA1 measures the levels of five tumor-secreted proteins (Beta-2 microglobulin, CA 125II, apolipoprotein A1, prealbumin and transferrin), while measuring the host response to ovarian cancer. Studies have shown that OVA1 improves the pre-surgical detection of ovarian cancer, regardless of stage or subtype, in patients with planned surgery for a suspicious mass.[3], [4]
About Moffitt Cancer Center
Located in Tampa, Moffitt is one of only 41 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt's excellence in research, its contributions to clinical trials, prevention and cancer control. Moffitt is the No. 1 cancer hospital in Florida and has been listed in U.S. News & World Report as one of "America's Best Hospitals" for cancer since 1999. With more than 4,200 employees, Moffitt has an economic impact on the state of nearly $2 billion. For more information, visit MOFFITT.org, and follow the Moffitt momentum on Facebook, Twitter and YouTube.
About Vermillion
Vermillion, Inc. (NASDAQ: VRML) is dedicated to the discovery, development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its prestigious scientific collaborators has diagnostic programs, dedicated to gynecologic oncology and women's health. Vermillion also announced in April 2014 the formation of a clinical laboratory, ASPiRA LABS, which is a wholly owned subsidiary of Vermillion.
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.
Forward-Looking Statements
Certain matters discussed in this press release contain forward-looking statements that involve significant risks and uncertainties, including statements regarding Vermillion's plans, objectives, expectations and intentions. These forward-looking statements are based on Vermillion's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Vermillion notes that 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 include but are not limited to: (1) uncertainty as to Vermillion's ability to protect and promote its proprietary technology; (2) Vermillion's lack of a lengthy track record successfully developing and commercializing diagnostic products; (3) uncertainty as to whether Vermillion will be able to obtain any required regulatory approval of its future diagnostic products; (4) uncertainty of the size of market for its existing diagnostic tests or future diagnostic products, including the risk that its products will not be competitive with products offered by other companies, or that users will not be entitled to receive adequate reimbursement for its products from third-party payers such as private insurance companies and government insurance plans; (5) uncertainty that Vermillion has sufficient cash resources to fully commercialize its tests and continue as a going concern; (6) uncertainty whether the trading in Vermillion's stock will become significantly less liquid; and (7) other factors that might be described from time to time in Vermillion's filings with the Securities and Exchange Commission. All information in this press release is as of the date of this report, and Vermillion expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Vermillion's expectations or any change in events, conditions or circumstances on which any such statement is based, unless required by law.
This release should be read in conjunction with the consolidated financial statements and notes thereto included in our 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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References:
1 National Cancer Institute. Seer Stat Fact Sheets – Ovarian Cancer. http://seer.cancer.gov/statfacts/html/ovary.html.
2 National Cancer Institute. Seer Stat Fact Sheets – Ovarian Cancer Trends in Rates. http://seer.cancer.gov/statfacts/html/ovary.html.
3 Goodrich ST, Bristow RE, Santoso JT, et al. The effect of ovarian imaging on the clinical interpretation of a multivariate index assay. Am J Obstet Gynecol (2014) doi: 10.1016/j.ajog.2014.02.010.
4 Ueland, FR, et al. Effectiveness of a Multivariate Index Assay in the Preoperative Assessment of Ovarian Tumors, Obstet Gynecol 2011;117:1289-97.
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SOURCE Vermillion, Inc.
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