FREMONT, Calif., Aug. 28 Vermillion, Inc.(Nasdaq: VRML), formerly Ciphergen Biosystems, today announced the publicationof research that details how a protein biomarker called beta-2 microglobulinmay aid in the diagnosis of peripheral artery disease (PAD). The findings,which suggest beta-2 microglobulin is elevated in patients with PAD and thatthe level of the protein is correlated with the severity of the disease, willbe published during September in Circulation and is currently online athttp://circ.ahajournals.org/.
Working with scientists at Stanford University, Vermillion intends todevelop a blood test for the diagnosis of PAD and the Company's developmentprogram is aimed at identifying and commercializing a panel of novelbiomarkers, which includes the newly discovered role of beta-2 microglobulin.
"Peripheral artery disease is a common disease, affecting approximately 10million Americans. Unfortunately, PAD is commonly unrecognized in patients,"said John Cooke, MD, PhD, Professor of Medicine at Stanford University andsenior author on the paper. "Patients with PAD are at high risk of heart andvessel complications unless they receive preventative treatment. A blood testwould be useful to identify individuals who are at risk for the condition andtriage them to further testing."
Over 370 patients at risk of PAD were intensively studied usingquestionnaires, blood tests, treadmill exercise, limb blood pressures andcoronary angiography. Proteomic profiling studies of the blood revealed aprotein that was higher in patients with PAD. In subsequent studies, theprotein was identified as beta-2 microglobulin.
Beta-2 microglobulin levels were correlated with the severity of disease,as determined by ankle blood pressures, and by the distance patients couldwalk on a treadmill. Beta 2microglobulin was an independent predictor, evenafter taking into consideration traditional risk factors such as cholesterol,diabetes, and age.
"This biomarker discovery may provide new insight into the pathophysiologyof peripheral artery disease and may contribute towards the development of ourpanel of biomarkers to identify patients at risk for PAD," said Eric T. Fung,M.D., Ph.D., Chief Scientific Officer for Vermillion. "We are engaged infinal validation studies to determine an optimal cutoff that stratifiespatients according to their likelihood of having peripheral artery disease."
As part of a strategic alliance agreement, Vermillion and QuestDiagnostics are working closely together to expedite development and releaseof the PAD test.
About Peripheral Artery Disease (PAD)
PAD, a serious but often asymptomatic disorder affecting some eight to 12million Americans, is caused by the buildup of fat and cholesterol, or plaque,in the peripheral arteries, disrupting normal blood flow. Left untreated, PADmore than doubles the risk of heart attack and stroke and increases the riskof amputation and death. There are treatments that can save the lives andlimbs of these patients, once the disease is recognized.
About Vermillion's Peripheral Artery Disease Program
Vermillion, in collaboration with Stanford University, is developing ablood-based assay for the detection of PAD. In January 2007, QuestDiagnostics accepted this program as the second of three diagnostic tests forjoint development under their existing strategic alliance agreement.
About Vermillion, Inc.
Vermillion, Inc. (formerly Ciphergen Biosystems, Inc.) is dedicated to thediscovery, development and commercialization of novel high-value diagnostictests that help physicians diagnose, treat and improve outcomes for patients.Vermillion, along with its prestigious scientific collaborators, has ongoingdiagnostic programs in oncology/hematology, cardiology and women's health withan initial focus in ovarian cancer. Based in Fremont, California,