Vermillion Summarizes Recent Accomplishments and 2007 Financ
FREMONT, Calif., March 4 /PRNewswire-FirstCall/ -- Vermillion, Inc. (Nasdaq: VRMLD - News), a molecular diagnostics company, today highlighted recent accomplishments across its diagnostic test programs and provided a preview of key business milestones it plans to achieve over the course of 2008. The Company also released financial results for the fourth quarter and year ended December 31, 2007.
"In 2007, Vermillion made significant clinical and commercial advancements in our diagnostic programs for peripheral artery disease (PAD), ovarian cancer and thrombotic thrombocytopenic purpura (TTP)," said Gail Page, President and CEO of Vermillion. "Our vision is to provide novel diagnostic tools to physicians in an effort to improve patient diagnosis and care. We continue to build awareness of the potential value proposition of our tests. Our primary focus will be on commercialization pathways in 2008."
Recent Accomplishments
Throughout the fourth quarter of 2007 and into the first quarter of 2008, Vermillion has advanced its PAD and ovarian cancer diagnostic programs, as well as accomplished numerous achievements at the corporate level:
PAD Diagnostic Test Progress -- Completed a 540-patient clinical study evaluating the ability of Vermillion''s multi-marker panel to stratify individuals into high and low risk groups for PAD. These results have been accepted for publication in a peer-reviewed clinical journal and are expected to be published in the first half of this year. -- Entered into an exclusive license agreement with Stanford University to develop and commercialize a biomarker panel used to assess the risk of PAD. Under the terms of the agreement, Vermillion is granted exclusive rights to the biomarker panel. Ovarian Cancer Diagnostic Test Progress -- Received the distinguished Society for Gynecologic Oncologists'' (SGO) Basic Science Poster Award for its abstract, "Prospective independent validation of a marker panel for distinguishing benign from malignant pelvic masses." The abstract, which demonstrated that the Company''s Ovarian Tumor Triage Test correctly identified 84 percent of ovarian cancer cases, compared to only 33 percent identified using standard diagnosis methods without the test, was presented at the SGO 38th Annual Meeting on Women''s Cancer last year in San Diego. -- Completed enrollment of 550 patients at 27 medical centers in a clinical trial to evaluate Vermillion''s Ovarian Tumor Triage Test to differentiate women with ovarian cancer from women with benign pelvic masses. -- Presented seven studies at the European Society for Gynecologic Oncology meeting describing advancements in Vermillion''s ovarian cancer diagnostic program. -- Data showed that Vermillion''s panel of ovarian cancer protein biomarkers in combination with CA-125 could more accurately identify early-stage ovarian cancer than could CA-125 alone. -- Data demonstrated that Vermillion''s ovarian cancer biomarker panel could accurately and with statistical significance predict women with ovarian cancer who had good prognosis from those who did not. The study used Kaplan-Meier analysis to show that women with a low panel score were significantly more likely to survive than women with high scores, independent of the stage of the disease. Corporate Developments -- Renewed a long-standing collaboration with Johns Hopkins University on the development of novel biomarkers that can be applied toward disease detection, classification and monitoring of prevalent cancers, including ovarian, breast and prostate. Vermillion will have access to exclusive commercial rights to the discoveries made through the partnership. -- Vermillion''s stockholders and board of directors approved a 1 for 10 reverse stock split of the Company''s common stock. The reverse split became effective at the close of trading on Monday, March 3, 2008. -- The Ohio State University commercially launched Vermillion''s diagnostic test for managing patients with TTP, a hematological disease. The test helps physicians make the correct diagnosis, initiate timely treatment, evaluate response to therapy and predict the risk of recurrence in patients with TTP. -- Received issuance of U.S. Patent No. 7,297,556 for aiding diagnosis of nephrotic syndrome, a kidney disorder marked by very high or low levels of protein in the urine, which results in bodily swelling and high cholesterol.
2008 Milestones
The Company''s primary goal for 2008 will be to commercialize its diagnostic tests through collaborations with Quest Diagnostics and other thought leaders in oncology, cardiology and hematology. Vermillion expects to attain the following milestones:
-- Present data from three studies highlighting progress in Vermillion''s ovarian cancer diagnostic program at the Society for Gynecologic Oncologists'' (SGO) 2008 Annual Meeting on Women''s Cancer held March 9-12 in Tampa, Florida. -- Report top-line data from the ovarian tumor triage clinical trial later this quarter and submit to the U.S. Food and Drug Administration (FDA) for clearance as an in vitro diagnostic test in the first half of 2008. -- Work with Quest Diagnostics to integrate Vermillion''s PAD proteomic biomarkers as a laboratory developed test. -- Establish a clinical steering committee to guide and provide advice on additional clinical studies to support registration of the PAD test with the FDA and to further potential market adoption. -- Continue to build the product pipeline by partnering with collaborators to identify and in-license biomarkers for future diagnostics.
Fourth Quarter and Year-End 2007 Results
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