Biomarker Panel Determines Risk of Peripheral Artery Disease

A multi-protein biomarker panel may aid in the diagnosis of peripheral artery disease (PAD).

A molecular diagnostics company presented data from a study providing confirmation that the company's multi-protein biomarker panel may aid in the diagnosis of peripheral artery disease (PAD). Results of the study suggest that such a panel will be useful in alerting physicians to the possibility of PAD in patients who might otherwise be undiagnosed.

Working in collaboration with scientists from Stanford University (Stanford, CA, USA), Vermillion (Fremont, CA, USA) intends to develop a blood test for the diagnosis of PAD. In March 2008, the company entered into an exclusive license agreement with the university to develop and commercialize a biomarker panel used to assess the risk of the PAD, which is estimated to affect up to 12 million people in the United States alone and can result in severe complications, including amputation, heart attack, stroke, and even death.

The study was conducted to develop an index score based on a combination of proposed biomarkers for PAD, including two based on proteomic discovery. A total of 540 patients were analyzed in the study. These patients were randomly selected from the ongoing GenePAD trial, which comprises individuals undergoing coronary angiography at Stanford University or Mount Sinai Medical Center (New York, NY, USA). Results of the study were presented as a poster at the American College of Cardiology 57th annual scientific session in Chicago, IL, USA, on March 29-April 1, 2008.

"Few studies have explored combinations of protein markers to create a distinct biomarker panel score to stratify individuals according to their risk of having PAD. However, our study successfully accomplishes this by discovering a multi-marker panel that could significantly aid in identifying such patients,” said Eric T. Fung, M.D., Ph.D., CSO of Vermillion. "We are pleased with these findings, and we are developing a clinical trial protocol to generate data for support of a submission to the U.S. Food and Drug Administration (FDA; Rockville, MD, USA).”

Vermillion discovers, develops, and commercializes diagnostic tests that help physicians diagnose, treat, and improve outcomes for patients. Vermillion, along with its scientific collaborators, has diagnostic programs in oncology, hematology, cardiology, and women's health.


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Mount Sinai Medical Center