WALTHAM, Mass.—BG Medicine Inc., a developer of diagnostics based on biomarkers, announced in late March that it has entered into a research collaboration agreement with Boston Scientific Corp., a medical device manufacturer, to study the role of galectin-3 as an aid in patient screening for cardiac-resynchronization therapy (CRT) using patient data from the MADIT-CRT study.
MADIT-CRT is the world's largest randomized CRT-D study of New York Heart Association (NYHA) Class I and II patients, with more than 1,800 patients enrolled at 110 centers worldwide. Results of the MADIT-CRT trial were published in the October 2009 issue of the New England Journal of Medicine.
The collaboration is designed to focus on better understanding the important MADIT-CRT patient population and whether galectin-3 can help identify patients who would derive the most benefit from CRT. This collaboration also involves using BG Medicine's biomarker discovery capabilities to identify other biomarkers that correlate to CRT treatment response.
The U.S. Food and Drug Administration recently cleared the BG Medicine galectin-3 assay as an aid in assessing the prognosis of patients with chronic heart failure. Elevated galectin-3 levels are associated with an inherently progressive form of heart failure that is associated with an increased risk of hospitalization or death.
According to the American Heart Association, heart failure affects an estimated 5.7 million Americans, with 670,000 new diagnoses each year. The estimated direct and indirect cost of this condition in the U.S. is $39.2 billion annually.
CRT, also known as bi-ventricular pacing, is a treatment for heart failure that uses an implantable device to improve the pumping efficiency of the heart. CRT has been shown to significantly reduce risk of death and hospitalization in certain groups of patients.
"Guidelines for CRT candidate selection are based on measures of current cardiac status, not on the basis of anticipated disease course," notes Dr. Pieter Muntendam, president and CEO of BG Medicine. "Elevated galectin-3 is associated with poor outcomes, and this collaboration aims to investigate the role galectin-3 can play in identifying those who stand to gain most by early use of CRTs."
MADIT-CRT is the world's largest randomized CRT-D study of New York Heart Association (NYHA) Class I and II patients, with more than 1,800 patients enrolled at 110 centers worldwide. Results of the MADIT-CRT trial were published in the October 2009 issue of the New England Journal of Medicine.
The collaboration is designed to focus on better understanding the important MADIT-CRT patient population and whether galectin-3 can help identify patients who would derive the most benefit from CRT. This collaboration also involves using BG Medicine's biomarker discovery capabilities to identify other biomarkers that correlate to CRT treatment response.
The U.S. Food and Drug Administration recently cleared the BG Medicine galectin-3 assay as an aid in assessing the prognosis of patients with chronic heart failure. Elevated galectin-3 levels are associated with an inherently progressive form of heart failure that is associated with an increased risk of hospitalization or death.
According to the American Heart Association, heart failure affects an estimated 5.7 million Americans, with 670,000 new diagnoses each year. The estimated direct and indirect cost of this condition in the U.S. is $39.2 billion annually.
CRT, also known as bi-ventricular pacing, is a treatment for heart failure that uses an implantable device to improve the pumping efficiency of the heart. CRT has been shown to significantly reduce risk of death and hospitalization in certain groups of patients.
"Guidelines for CRT candidate selection are based on measures of current cardiac status, not on the basis of anticipated disease course," notes Dr. Pieter Muntendam, president and CEO of BG Medicine. "Elevated galectin-3 is associated with poor outcomes, and this collaboration aims to investigate the role galectin-3 can play in identifying those who stand to gain most by early use of CRTs."
