FREMONT, Calif. and DENVER, May 19 /PRNewswire-FirstCall/ -- Vermillion, Inc. today announced that it has selected Colorado Prevention Center (CPC) as its academic research organization of choice for the design of a clinical study to support clearance of VASCLIR(TM), the Company's peripheral artery disease (PAD) blood test, with the U.S. Food and Drug Administration (FDA). VASCLIR is a simple blood test that may help determine an individual's risk of having PAD, a serious condition estimated to affect up to 12 million Americans.
"The selection of CPC to support our PAD clinical program is an important milestone in our product development and commercialization efforts," said Gail S. Page, President and CEO of Vermillion. "We selected CPC because of its extensive experience in designing and executing high-quality, cost-effective clinical studies in the field of cardiovascular disease."
"We are pleased to partner with Vermillion on their clinical program for VASCLIR," said William Hiatt, M.D., President of the Colorado Prevention Center, and Professor of Medicine and Chief of the Section of Vascular Medicine at the University of Colorado Denver School of Medicine. "Research indicates that within five years of being diagnosed with PAD, one in four patients will suffer a major adverse event, such as heart attack, stroke, amputation or even death. This statistic exemplifies the need for a new blood test that can provide information to doctors and their patients about the risk that a patient may have PAD. Such a blood test could allow earlier measures to be taken to prevent the serious consequences of the disease."
About PAD
PAD, a serious but often asymptomatic disorder affecting some eight to 12 million Americans, is caused by the buildup of fat and cholesterol, or plaque, in the peripheral arteries, particularly often the legs, disrupting normal blood flow. Left untreated, PAD more than doubles the risk of heart attack and stroke and increases the risk of amputation and death. There are treatments that can save the lives and limbs of these patients, once the disease is recognized.
In late 2007, Vermillion completed a 540-patient clinical study evaluating the ability of its test 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 later this year. Additionally, Vermillion recently established a scientific steering committee to guide and provide advice on a clinical trial to support clearance of VASCLIR with the FDA and to further potential market adoption.
About Colorado Prevention Center
CPC is an academic research organization dedicated to improving health through clinical research and integrating scientific evidence into community prevention programs. As an ARO, CPC provides trial management services that support every aspect of clinical research, including study design, biostatistics and data management, comprehensive trial management, specialized endpoint evaluation services, ECG and wound core lab services, and completion of final study reports. CPC is an affiliate of the University of Colorado Denver School of Medicine.
About Vermillion
Vermillion, Inc. 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, hematology, cardiology and women's health. Vermillion is based in Fremont, California. Additional information about Vermillion can be found on the Web at www.vermillion.com.
Forward Looking Statements
This news release contains forward-looking statements that involve significant risks and uncertainties, including the risks and uncertainties discussed in Vermillion's Form 10-K for the year ended December 31, 2007, and Vermillion's periodic reports on Form 10-Q and Form 8-K. Vermillion is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. Forward-looking statements cannot be guaranteed and actual results may differ materially from Vermillion's current expectations. You are encouraged to read Vermillion's reports filed with the U.S. Securities and Exchange Commission, available at http://www.sec.gov and http://www.vermillion.com under "Investor Relations."
CONTACT: Investors: Sue Carruthers, Vermillion, Inc., +1-510-505-2233;
Media: Daryl Messinger, WeissComm Partners, +1-415-946-1062, for
Vermillion, Inc.; Evan King, Chief Operating Officer, Colorado Prevention
Center, Evan.king@cpcmed.org
Web site: http://www.vermillion.com/
