Vermillion Supports First World Ovarian Cancer Day and Effort to Raise Awareness of the Need for Better Diagnosis and Treatment Vermillion Offers Women New Hope with OVA1, a FDA-Cleared Test Designed to Aid in the Prediction of Malignancy Prior to Surgery on an Ovarian Mass
AUSTIN, Texas, May 8, 2013 /PRNewswire/ -- Vermillion, Inc. (NASDAQ: VRML), a molecular diagnostics company focused on gynecologic cancers and women's health, joins ovarian cancer organizations around the world in recognizing May 8 as World Ovarian Cancer Day.
On this day, ovarian cancer organizations are uniting to educate their communities about ovarian cancer and its symptoms. For women living with the disease, and their families and friends, World Ovarian Cancer Day represents a global expression of solidarity in the fight against the disease.
"We commend the organizers of this First World Ovarian Cancer Day for bringing together 26 ovarian cancer organizations across 17 countries to generate greater awareness about this deadly disease," said Thomas McLain, Vermillion's president and chief executive officer. "Given the lethality of ovarian cancer and how often it goes undetected before it's too late, we need to increase public knowledge about its symptoms as well as the critical importance of early and appropriate treatment."
According to Ovariancancerday.org, every year ovarian cancer is diagnosed in nearly a quarter of a million women around the world, leading to 140,000 cancer-related deaths. In the U.S., out of the 22,000 women who are diagnosed with ovarian cancer every year, 81% are diagnosed as malignant only after the cancer had spread to other parts of the body (metastases). However, only one in three women with ovarian cancer are initially treated by a gynecologic oncologist, in part due to inadequate diagnostic tests and procedures. These statistics reveal how early detection and proper treatment by a gynecologic oncologist can be the key to survival.
Recent stories in the media have highlighted the deficiencies in the detection and treatment of ovarian cancer, including coverage by the New York Times and NBC Nightly News. According to Dr. Bristow, the director of gynecologic oncology services at UC Irvine Healthcare and principal investigator of the study highlighted in these articles, "If we could just make sure that women get to the people who are trained to take care of them, the impact would be much greater than that of any new chemotherapy drug or biological agent."
Vermillion, which has been dedicated to addressing these deficiencies, has achieved remarkable results with its OVA1® test, the first FDA-cleared test designed to aid in the prediction of malignancy prior to surgery on an ovarian mass. Vermillion developed the OVA1 test together with Johns Hopkins University after nearly a decade of proteomic research. In two published clinical studies, OVA1 demonstrated 96% sensitivity across a broad range of ovarian malignancies and detected over 90% of all early stage ovarian cancers. The studies also reported a 95%-98% negative predictive value, a critical feature for minimizing the likelihood that a non-oncology surgeon discovers ovarian cancer during surgery. The powerful performance of OVA1 helps to ensure that women with ovarian cancer are treated by a gynecologic oncologist, which is a critical determinant of survival.
Since receiving FDA clearance in 2009, Vermillion has worked to increase insurance coverage for the test, as well as greater use by physicians.
"Despite the strong progress we've made, with more than 42,000 test performed to-date, the adoption rate of OVA1 has been far too slow," noted McLain "We are hopeful that a special day dedicated to building ovarian cancer awareness can help bring about the changes we need in healthcare policy, insurance coverage and guidelines which would better support OVA1 as the standard of care in the diagnosis and treatment of ovarian cancer."
For more information about OVA1, visit www.vermillion.com. Vermillion has also made information about the signs, symptoms and treatment of ovarian cancer, as well as links to various cancer and advocacy organizations, available at www.vermillion.com/gynecologic-cancer-overview.
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 in oncology, vascular medicine and women's health.
The company's lead diagnostic, OVA1®, is a blood test for pre-surgical assessment of tumors for malignancy, using a unique multi-biomarker approach. In a published clinical trial, OVA1 achieved 99% sensitivity in detecting epithelial ovarian cancers (EOC). This included 96% sensitivity for stage I EOC, the earliest and most curable EOC stage, compared with 57% for the conventional biomarker CA125. In addition, OVA1 found 82% of malignancies missed by non-specialist pre-surgical assessment, and it increased detection of malignancy over ACOG guidelines from 77% to 94%. As the first protein-based, In Vitro Diagnostic Multivariate Index Assay (IVDMIA) cleared by the FDA, OVA1 also represents a new class of software-based diagnostics. Additional information about these published clinical trials is available on Vermillion's website at www.vermillion.com.
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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