BG Medicine Announces FDA 510(k) Clearance of its Galectin-3 Test
WALTHAM, MA (BUSINESS WIRE)— BG Medicine, Inc., a U.S.-based life sciences company, announced today that the U.S. Food and Drug Administration has cleared the company’s Galectin-3 test for use in conjunction with clinical evaluation as an aid to assess the prognosis of patients diagnosed with chronic heart failure. This marks the first time the FDA has cleared a test to measure galectin-3 blood levels, and is the first novel cardiac test cleared by the FDA in five years.
Galectin-3 is a protein that has been shown to play an important role in the development and progression of heart failure in approximately 30% of the patients diagnosed with heart failure. This galectin-3 mediated form of heart failure is associated with progressive fibrosis, or stiffening, in the heart muscle, which impairs the heart's ability to pump. The role of galectin-3 in heart failure was first established in 2004, and the clearance of the company’s Galectin-3 blood test now for the first time allows physicians to use this product in the evaluation of patients diagnosed with heart failure.
“The availability of a galectin-3 test to identify high risk patients with cardiovascular disease and Myocardial fibrosis represents another step toward the goal of enabling more efficient targeting of therapeutic approaches to reduce fibrosis in patients with chronic heart failure,"
said Bertram Pitt, M.D., F.A.C.C., professor of internal medicine, Division of Cardiology, University of Michigan School of Medicine.
Heart failure is caused by a combination of factors that reduce blood flow and damage or overwork the heart muscle, so that it cannot circulate blood efficiently to meet the needs of other body organs. Heart failure may lead to serious medical complications and is a leading cause of death. According to the American Heart Association, heart failure affects an estimated 5.8 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.
"In recent times many major medical conditions have been redefined from a classical definition based on signs and symptoms to a science-based definition taking into account the underlying biology. With the introduction of our Galectin-3 test, we are offering physicians the first opportunity to identify those patients with higher levels of galectin-3. Galectin-3 has been implicated in important biological processes in heart failure, including myofibroblast proliferation, fibrogenesis, and cardiac remodeling,"
indicated Pieter Muntendam, M.D., president and chief executive officer of BG Medicine.
"It is an important step towards improved medical management in heart failure."
The BGM Galectin-3 test is based on the common ELISA format using the standard microtiter plate presentation. BG Medicine is currently finalizing its commercialization plans with LabCorp, one of the world's largest clinical laboratories, in order to make the BGM Galectin-3 test available within 45 days of the FDA clearance.
BG Medicine has also entered into agreements with Abbott Laboratories (NYSE: ABT), Alere Inc. (NYSE: ALR), and bioMérieux SA (EURONEXT: BIM) for the development and commercialization of automated versions of the BGM Galectin-3 test for Abbott’s Architect immunochemistry instrument platform (i1000SR and i2000SR), Abbott's hand-held i-STAT System, Alere’s Triage Meter Pro and the bioMérieux VIDAS/miniVIDAS systems.
About BG Medicine
BG Medicine is a life sciences company focused on the discovery, development, and commercialization of novel diagnostics to improve patient outcomes and contain healthcare costs. For further information about galectin-3 and the BGM Galectin-3 test, visit www.galectin-3.com.